Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3df8005f-b26d-48fa-97bd-02fc9ac0275e
Route
TOPICAL
Published
Effective Date 2015-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg) Octisalate (20 mg)
Inactive Ingredients
Water C12-15 Alkyl Benzoate Diethylhexyl 2,6-naphthalate Cetostearyl Alcohol Dimethicone Cyclomethicone 5 Glycerin Cyclomethicone 6 Arachidyl Alcohol Phenyl Trimethicone Phenoxyethanol Cetearyl Glucoside Panthenol Benzyl Alcohol Nylon-12 Tanacetum Parthenium Docosanol Steareth-2 Steareth-21 Polyacrylamide (10000 Mw) Arachidyl Glucoside Edetate Disodium C13-14 Isoparaffin Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sarcosine Laureth-7 Ethylhexylglycerin Iodopropynyl Butylcarbamate Potassium Aspartate Magnesium Aspartate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-16
Description

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

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
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • Sun Protection Measure.  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.
Do Not Use

on damaged or broken skin.

Label Copy

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Cetearyl Alcohol, Dimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cetearyl Glucoside, Panthenol, Benzyl Alcohol, Nylon-10/10, Chrysanthemum Parthenium (Feverfew) Extract, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Steareth-21, Fragrance, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Ethylhexylglycerin, Iodopropynyl Butylcarbamate, Potassium Aspartate, Magnesium Aspartate.

Questions Or Comments?

1-800-746-7287

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.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

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
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: Ask a doctor.
  • Sun Protection Measure.  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.
Do Not Use (Do not use)

on damaged or broken skin.

Label Copy

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 2%

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Cetearyl Alcohol, Dimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Arachidyl Alcohol, Phenyl Trimethicone, Phenoxyethanol, Cetearyl Glucoside, Panthenol, Benzyl Alcohol, Nylon-10/10, Chrysanthemum Parthenium (Feverfew) Extract, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Steareth-21, Fragrance, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Ethylhexylglycerin, Iodopropynyl Butylcarbamate, Potassium Aspartate, Magnesium Aspartate.

Questions Or Comments? (Questions or comments?)

1-800-746-7287

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

rash occurs.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:01.378224 · Updated: 2026-03-14T22:54:11.557814