Lather - Daily Defense Mineral Spf 50 (77394-202)

Lather - Daily Defense Mineral Spf 50 (77394-202)
SPL v12
SPL
SPL Set ID 81cf57b0-6072-432f-b421-7d1a708da1c4
Route
TOPICAL
Published
Effective Date 2021-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (21 g)
Inactive Ingredients
Coco-caprylate/caprate Cetyl Alcohol Propanediol Water Stearyl Alcohol Polyhydroxystearic Acid (2300 Mw) Mica Butyrospermum Parkii (shea) Butter Unsaponifiables Cetearyl Olivate Sorbitan Olivate Camellia Sinensis Flower Olea Europaea (olive) Oil Unsaponifiables Equisetum Arvense Whole Rosmarinus Officinalis Flower Centella Asiatica Aesculus Hippocastanum Flower Cocos Nucifera Whole Helianthus Annuus Seed Wax Glyceryl Caprylate Glycerin Xanthan Gum .alpha.-tocopherol Acetate Citrus Nobilis Silicon Dioxide Caprylhydroxamic Acid Triethoxycaprylylsilane Ascorbyl Palmitate Caprylic/capric/succinic Triglyceride Ascorbic Acid Tocopherol Potassium Sorbate Phytate Sodium Citric Acid Acetate Brown Iron Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Zinc Oxide 21%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 21%

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 caused by the sun
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Warnings
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
Directions
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  •      immediately after towel drying
  •      at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  •      children under 6 months of age: ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun
Active Ingredients

Zinc Oxide 21%

Inactive Ingredients

Water (aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Caprylate, Glycerin, Xanthan Gum, Tocopheryl Acetate, Citrus Nobilis (Mandarin Orange) Peel Oil, Silica, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Potassium Sorbate, Sodium Phytate, Citric Acid, Iron Oxides


Structured Label Content

Uses (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 caused by the sun
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)
  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure
  • reapply: after 80 minutes of swimming or sweating
  •      immediately after towel drying
  •      at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  •      children under 6 months of age: ask a doctor
Other Information (OTHER INFORMATION)
  • Protect this product from excessive heat and direct sun
Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide 21%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Caprylate, Glycerin, Xanthan Gum, Tocopheryl Acetate, Citrus Nobilis (Mandarin Orange) Peel Oil, Silica, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Potassium Sorbate, Sodium Phytate, Citric Acid, Iron Oxides


Advanced Ingredient Data


Raw Label Data

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