Sheer Mineral Spf30 Moist Tube (mineral Sun Defense Moisturizer Broad Spectrum Sunscreen Spf 30)

Sheer Mineral Spf30 Moist Tube (mineral Sun Defense Moisturizer Broad Spectrum Sunscreen Spf 30)
SPL v1
SPL
SPL Set ID 18e4c50d-eb91-c269-e063-6394a90a7999
Route
TOPICAL
Published
Effective Date 2024-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.169 g) Zinc Oxide (9.693 g)
Inactive Ingredients
Ethyl Macadamiate Orange Oil Lauroyl Lysine Argan Oil .alpha.-tocopherol Acetate Leuconostoc/radish Root Ferment Filtrate Coco-caprylate/caprate Geranium Oil, Algerian Type Avocado Oil Tocopherol Aluminum Oxide Saccharomyces Cerevisiae Octyldodecyl Erucate Sunflower Oil Glyceryl Caprylate Amyris Balsamifera Oil Vetiver Oil Stearic Acid Shea Butter Glycerin Glyceryl 1-undecylenate Malic Acid Castor Oil Linalool, (+/-)- Galbanum Dilinoleic Acid/butanediol Copolymer Green Tea Leaf Punica Granatum Root Bark Candelilla Wax Lavandin Oil Polyglyceryl-6 Polyricinoleate Vitis Vinifera Seed Lycium Barbarum Fruit Citral Litsea Oil Pogostemon Cablin Leaf Oil Ginger Oil Aspalathus Linearis Leaf Limonene, (+)- Behenyl Behenate Polyhydroxystearic Acid (2300 Mw) Juniper Berry Oil Ferric Oxide Red Medium-chain Triglycerides Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s)

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-08

Description

Active Ingredients Titanium Dioxide................4.31% Zinc Oxide .......................19.27%


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses

• helps prevent sunburn.

• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging cause by the sun.

Dosage and Administration

Directions

• Apply liberally 15 minutes before sun exposure

• Reapply every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.- 2 p.m.

• wear long sleeved shirts, pants, hats and sunglasses

Description

Active Ingredients Titanium Dioxide................4.31% Zinc Oxide .......................19.27%

Section 50565-1

Keep out of reach of children.

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

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients

Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

Section 51945-4

Section 53413-1

Questions or comments? Call toll free 1-866-586-3522

Section 55105-1

Sunscreen

Section 55106-9

Active Ingredients

Titanium Dioxide................4.31%

Zinc Oxide .......................19.27%

Section 60561-8

Other information • Protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

Uses

• helps prevent sunburn.

• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging cause by the sun.

Dosage and Administration (34068-7)

Directions

• Apply liberally 15 minutes before sun exposure

• Reapply every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.- 2 p.m.

• wear long sleeved shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

Warnings For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients

Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco-Caprylate/Caprate, Behenyl Behenate, Sorbitol/ Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call toll free 1-866-586-3522

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Titanium Dioxide................4.31%

Zinc Oxide .......................19.27%

Section 60561-8 (60561-8)

Other information • Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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