SPL v6
SPL
SPL Set ID b5e68448-4131-1c6c-e053-2a95a90a014a
Route
TOPICAL
Published
Effective Date 2020-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.5 g) Oxybenzone (1.5 g)
Inactive Ingredients
Cymbopogon Schoenanthus Top Althaea Officinalis Root Achillea Millefolium Flower Green Tea Leaf Stearic Acid Glyceryl Stearate Se Titanium Dioxide Cetyl Dimethicone 150 Glycerin Sodium Hydroxide Cetostearyl Alcohol Polysorbate 60 Tricontanyl Povidone High Density Polyethylene Water Aloe Vera Leaf Carrageenan Chamomile Symphytum Uplandicum Leaf Comfrey Root Taraxacum Officinale Leaf Echinacea, Unspecified Sambucus Nigra Flower American Ginseng Macrocystis Pyrifera Lavandula Angustifolia Flowering Top Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Methylparaben Cetyl Alcohol Diazolidinyl Urea Propylparaben Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-22
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • helps prevent sunburn
Section 42229-5

Drug Facts

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 50566-9

Stop use and ask a doctor if rash occurs

Section 50570-1

Do not use on damaged or broken skin

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

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

For external use only

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
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Octinoxate 4.5%

Oxybenzone 1.5%

Inactive Ingredients

aqueous extracts of: aloe barbadensis leaf extract, algae extract, chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, stearic acid, glyceryl stearate se, cetyl dimethicone, glycerin, tricontanyl-pvp, polyethylene, cetyl alcohol, methylparaben, propylparaben, diazolidinyl urea, fragrance, sodium hydroxide, acrylates/c10-30 alkyl acrylates cross-polymer, and theobroma cacao (cocoa) seed butter.

Questions Or Comments?

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label

192 ml NDC: 52854-908-01

Structured Label Content

Uses
  • helps prevent sunburn
Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

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

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

For external use only

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
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Octinoxate 4.5%

Oxybenzone 1.5%

Inactive Ingredients

aqueous extracts of: aloe barbadensis leaf extract, algae extract, chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, stearic acid, glyceryl stearate se, cetyl dimethicone, glycerin, tricontanyl-pvp, polyethylene, cetyl alcohol, methylparaben, propylparaben, diazolidinyl urea, fragrance, sodium hydroxide, acrylates/c10-30 alkyl acrylates cross-polymer, and theobroma cacao (cocoa) seed butter.

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-368-7327

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

192 ml NDC: 52854-908-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:11.936545 · Updated: 2026-03-14T23:13:25.872506