Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 09aebff5-d606-47bc-a51c-b27367ae51c9
Route
TOPICAL
Published
Effective Date 2013-06-14
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 Cetostearyl Alcohol Dimethicone Soybean Glycerin Dimethicone Peg-15 Acetate Arachidyl Alcohol Phenoxyethanol Cetearyl Glucoside Panthenol Benzyl Alcohol Trimethylolpropane Triacrylate Docosanol Steareth-2 Steareth-21 Polyacrylamide (10000 Mw) Methyl Methacrylate Arachidyl Glucoside Edetate Disodium Methylparaben C13-14 Isoparaffin Ethylparaben Butylparaben Laureth-7 Benzalkonium Chloride Propylparaben Isobutylparaben Butylated Hydroxytoluene Iodopropynyl Butylcarbamate Mica Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-10
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.

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 (AQUA), C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, DIMETHICONE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCERIN, BIS-PHENYLPROPYL DIMETHICONE, ARACHIDYL ALCOHOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, PANTHENOL, BENZYL ALCOHOL, ETHYLENE/ACRYLIC ACID COPOLYMER, BEHENYL ALCOHOL, STEARETH-2, FRAGRANCE (PARFUM), STEARETH-21, POLYACRYLAMIDE, POLYMETHYL METHACRYLATE, ARACHIDYL GLUCOSIDE, DISODIUM EDTA, METHYLPARABEN, C13-14 ISOPARAFFIN, ETHYLPARABEN, BUTYLPARABEN, LAURETH-7, BENZALKONIUM CHLORIDE, PROPYLPARABEN, ISOBUTYLPARABEN, BHT, IODOPROPYNYL BUTYLCARBAMATE, MICA, SILICA, TITANIUM DIOXIDE.

Questions Or Comments?

1-800-746-7287

Sun Protection Measures

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER 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.

When Using This Product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If

RASH OCCURS.

Structured Label Content

Use(s) (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 (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (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.

Do Not Use (DO NOT USE)

ON DAMAGED OR BROKEN SKIN.

Label Copy (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 (AQUA), C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, DIMETHICONE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCERIN, BIS-PHENYLPROPYL DIMETHICONE, ARACHIDYL ALCOHOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, PANTHENOL, BENZYL ALCOHOL, ETHYLENE/ACRYLIC ACID COPOLYMER, BEHENYL ALCOHOL, STEARETH-2, FRAGRANCE (PARFUM), STEARETH-21, POLYACRYLAMIDE, POLYMETHYL METHACRYLATE, ARACHIDYL GLUCOSIDE, DISODIUM EDTA, METHYLPARABEN, C13-14 ISOPARAFFIN, ETHYLPARABEN, BUTYLPARABEN, LAURETH-7, BENZALKONIUM CHLORIDE, PROPYLPARABEN, ISOBUTYLPARABEN, BHT, IODOPROPYNYL BUTYLCARBAMATE, MICA, SILICA, TITANIUM DIOXIDE.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-746-7287

Sun Protection Measures (SUN PROTECTION MEASURES)

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER 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.

When Using This Product (WHEN USING THIS PRODUCT)

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

RASH OCCURS.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:38.705257 · Updated: 2026-03-14T22:53:30.775793