Every Day Mineral Sun Screen Spf 45

Every Day Mineral Sun Screen Spf 45
SPL v7
SPL
SPL Set ID 7ec4954f-7d60-405b-8bff-cb602fc44a4e
Route
TOPICAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (190 mg)
Inactive Ingredients
Water Aloe Vera Leaf Coco-caprylate Isoamyl Laurate Glycerin Polyglyceryl-3 Oleate Propanediol Polyhydroxystearic Acid (2300 Mw) Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Mica Tricaprin Sodium Chloride Ethyl Lauroyl Arginate Hydrochloride Hydrolyzed Jojoba Esters (acid Form) Olive Oil Alaria Esculenta Olea Europaea Leaf Green Tea Leaf Holy Basil Leaf Coconut Oil Turmeric Tetrasodium Glutamate Diacetate Tocopherol Sodium Stearoyl Glutamate Silicon Dioxide Xanthan Gum Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-11

Description

Drug Facts Active ingredients Zinc Oxide 19% (Non-Nano)


Medication Information

Warnings and Precautions

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse with water to remove.
Indications and Usage

Uses

  • Helps prevent sunburn
Description

Drug Facts Active ingredients Zinc Oxide 19% (Non-Nano)

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Every Day Mineral Sun Screen Active SPF 45 (75mL, 50mL and 946mL) & Natural Mineral Sunscreen Extreme Elements SPF 45 (75mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen Tint SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Iron Oxides, (C.I.77492, C.I.77491, C.I.77499).



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen 4 Kids SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen Shimmer SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492



*ORGANIC INGREDIENTS

Happy Ocean Mineral Sunscreen SPF 45 (75mL) and Happy Ocean Kids Mineral Sunscreen SPF 45 (75mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl Lauroyl Arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492



*ORGANIC INGREDIENTS

Makai Beauty SPF 45 Mineral Sunscreen (75mL) and Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL)

Aloe Barbadensis Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root* Extract, Deionized Water, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Hibiscus Sabdariffa Flower Extract, Chamomilla Recutita (Chamomile) Extract, Camellia Sinensis Leaf (White Tea) Extract, Alaria Esculenta (Wakame Seaweed) Extract, Camellia Sinensis (Green Tea) Leaf Extract*, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europaea (Olive) Leaf Extract* in Cocos Nucifera (Coconut) Oil, Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum

*ORGANIC INGREDIENTS

Makai CC Cream

Deionized Water, Aqueous Extracts (Chamomile, Green Tea Leaf*, Hibiscus, Olive Leaf*, Tulsi Leaf*, Wakame Seaweed*), Caprylic/Capric Triglyceride, Aloe Leaf Juice, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhdroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Olive Squalane Oil, Coconut Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides (CI 77492, CI 77491, CI 77499), Jojoba Esters

*ORGANIC INGREDIENTS

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Drug Facts

Active ingredients

Zinc Oxide 19% (Non-Nano)

Section 60561-8

Other info

Protect this product from excessive heat & sunlight.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Package Label.principal Display Panel

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (75mL) - LABEL

NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (946mL) - LABEL

HAPPY OCEAN MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

HAPPY OCEAN KIDS MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

MAKAI BEAUTY SPF 45 MINERAL SUNSCREEN, 75 ML - LABEL

Makai Beauty CC Cream SPF 45, 30mL - Label

Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps prevent sunburn
Warnings and Precautions (34071-1)

Warnings

  • For external use only.
  • Do not use on damaged or broken skin.
  • Stop use and ask a doctor if rash occurs.
  • When using this product, keep out of eyes. Rinse with water to remove.
Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Every Day Mineral Sun Screen Active SPF 45 (75mL, 50mL and 946mL) & Natural Mineral Sunscreen Extreme Elements SPF 45 (75mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen Tint SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Iron Oxides, (C.I.77492, C.I.77491, C.I.77499).



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen 4 Kids SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinenis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum.



*ORGANIC INGREDIENTS

Every Day Mineral Sun Screen Shimmer SPF 45 (75mL, 50mL and 946mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl lauroyl arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492



*ORGANIC INGREDIENTS

Happy Ocean Mineral Sunscreen SPF 45 (75mL) and Happy Ocean Kids Mineral Sunscreen SPF 45 (75mL)

Deionized Water, Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Vegetarian Glycerin, Polyglyceryl- 3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyglyceryl- 3 Dimer Dinoleate, Mica, Caprylic/Capric Triglyceride, Sodium Chloride, Ethyl Lauroyl Arginate HCl, Jojoba Esters, Olive Squalane Oil, Extracts of Alaria Esculenta (Wakame Seaweed), Olea Europa (Olive) Leaf*, Camellia Sinensis (Green Tea) Leaf*, Ocimum Tinuiflorum (Tulsi) Leaf*, Cocos Nucifera (Coconut) Oil, Curcuma Longa (Turmeric) Root* Extract, Tetrasodium Glutamate Diacetate, Mixed Tocopherols, Sodium Stearoyl Glutamate, Silica, Xanthan Gum, Calcium Sodium Borosilicate (and) Iron Oxides C.I.77492



*ORGANIC INGREDIENTS

Makai Beauty SPF 45 Mineral Sunscreen (75mL) and Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL)

Aloe Barbadensis Leaf Juice*, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Curcuma Longa (Turmeric) Root* Extract, Deionized Water, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethyl Lauroyl Arginate HCl, Hibiscus Sabdariffa Flower Extract, Chamomilla Recutita (Chamomile) Extract, Camellia Sinensis Leaf (White Tea) Extract, Alaria Esculenta (Wakame Seaweed) Extract, Camellia Sinensis (Green Tea) Leaf Extract*, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europaea (Olive) Leaf Extract* in Cocos Nucifera (Coconut) Oil, Isoamyl Laurate, Jojoba Esters, Mica, Mixed Tocopherols, Olive Squalane Oil, Polyglyceryl-3 Oleate, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Chloride, Sodium Stearoyl glutamate, Tetrasodium Glutamate Diacetate, Vegetarian Glycerin, Xanthan Gum

*ORGANIC INGREDIENTS

Makai CC Cream

Deionized Water, Aqueous Extracts (Chamomile, Green Tea Leaf*, Hibiscus, Olive Leaf*, Tulsi Leaf*, Wakame Seaweed*), Caprylic/Capric Triglyceride, Aloe Leaf Juice, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhdroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Olive Squalane Oil, Coconut Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides (CI 77492, CI 77491, CI 77499), Jojoba Esters

*ORGANIC INGREDIENTS

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

Zinc Oxide 19% (Non-Nano)

Section 60561-8 (60561-8)

Other info

Protect this product from excessive heat & sunlight.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours.
  • For children under 6 months of age; ask a doctor.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (75mL) - LABEL

NATURAL MINERAL SUNSCREEN EXTREME ELEMENTS SPF 45

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN ACTIVE SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN TINT SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN 4 KIDS SPF 45 (946mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (75mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (50mL) - LABEL

EVERY DAY MINERAL SUNSCREEN SHIMMER SPF 45 (946mL) - LABEL

HAPPY OCEAN MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

HAPPY OCEAN KIDS MINERAL SUNSCREEN SPF 45 (75mL) - LABEL

MAKAI BEAUTY SPF 45 MINERAL SUNSCREEN, 75 ML - LABEL

Makai Beauty CC Cream SPF 45, 30mL - Label

Counting Coral Everyday Mineral Sunscreen SPF 45 (75mL)


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