Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6f806d1d-c5f0-4a87-87f7-aa81033ae3b1
Route
TOPICAL
Published
Effective Date 2018-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (20 mg) Oxybenzone (40 mg) Zinc Cation (38 mg)
Inactive Ingredients
Water Neopentyl Glycol Diheptanoate Styrene/acrylamide Copolymer (500000 Mw) Cetostearyl Alcohol Glycerin Potassium Cetyl Phosphate Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Polysorbate 80 Isohexadecane Benzyl Alcohol Xanthan Gum Tetrasodium Glutamate Diacetate Lactic Acid Tetrahexyldecyl Ascorbate Crambe Hispanica Subsp. Abyssinica Seed Oil Iodopropynyl Butylcarbamate Panthenol Green Tea Leaf Aspalathus Linearis Leaf Aloe Vera Leaf Maritime Pine Adansonia Digitata Seed Tea Tree Oil Cannabis Sativa Seed Ascorbyl Glucoside Phytonadione Niacinamide Cyanocobalamin .alpha.-tocopherol Acetate, Dl- Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-06-01
Description

Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

Use(s)
  • 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.
Warnings

For external use only.

Directions

​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 Broad Spectrum SPF value of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • use a water resistant sunscreen if swimming or sweating.
  • reapply at least every 2 hours.
  • children under 6 months: ask doctor
Do Not Use

on damaged or broken skin.

Label Copy

Questions?

Call toll-free 1-855-760-3569

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

Inactive Ingredients

Water (Aqua), Butylene Glycol Cocoate, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Glycerin, Acetamidoethoxyethanol, Potassium Cetyl Phosphate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 80, Isohexadecane, Benzyl Alcohol, Xanthan Gum, Tetrasodium Glutamate Diacetate, Fragrance (Parfum), Lactic Acid, Triethoxycaprylylsilane, Tetrahexydecyl Ascorbate, Crambe Abyssinica Seed Oil, Panthenol, Hydrolyzed Keratin, Camellia Sinensis Leaf Extract, Aspalathus Linearis Leaf Extract, Aloe Barbadensis Leaf Juice, Pinus Pinaster Bark Extract, Hydrolyzed Adansonia Digitata Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hydrolyzed Hemp Protein, Hydrolyzed Vegetable Protein, Ascorbyl Glucoside, Phytonadione, Niacinamide, Cyanocobalamin, Tocopheryl Acetate, Iodopropynyl Butylcarbamate.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children

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

Structured Label Content

Use(s)
  • 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.
Purpose

Sunscreen

Warnings

For external use only.

Directions

​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 Broad Spectrum SPF value of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • use a water resistant sunscreen if swimming or sweating.
  • reapply at least every 2 hours.
  • children under 6 months: ask doctor
Do Not Use (Do not use)

on damaged or broken skin.

Label Copy

Questions?

Call toll-free 1-855-760-3569

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Butylene Glycol Cocoate, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Glycerin, Acetamidoethoxyethanol, Potassium Cetyl Phosphate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 80, Isohexadecane, Benzyl Alcohol, Xanthan Gum, Tetrasodium Glutamate Diacetate, Fragrance (Parfum), Lactic Acid, Triethoxycaprylylsilane, Tetrahexydecyl Ascorbate, Crambe Abyssinica Seed Oil, Panthenol, Hydrolyzed Keratin, Camellia Sinensis Leaf Extract, Aspalathus Linearis Leaf Extract, Aloe Barbadensis Leaf Juice, Pinus Pinaster Bark Extract, Hydrolyzed Adansonia Digitata Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hydrolyzed Hemp Protein, Hydrolyzed Vegetable Protein, Ascorbyl Glucoside, Phytonadione, Niacinamide, Cyanocobalamin, Tocopheryl Acetate, Iodopropynyl Butylcarbamate.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.836444 · Updated: 2026-03-14T22:55:08.159087