Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3be777bd-9132-4a69-98de-12b62525ad2f
Route
CUTANEOUS
Published
Effective Date 2011-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.9 mL) Octisalate (3.15 mL)
Inactive Ingredients
Water Propylene Glycol Cetostearyl Alcohol Cetyl Alcohol Hydroxyethyl Urea Lavandula Angustifolia Flowering Top C14-22 Alcohols Polysorbate 80 Glyceryl Monostearate Peg-100 Stearate Dimethicone Phenoxyethanol C12-20 Alkyl Glucoside Methylparaben Isohexadecane Chamomile Goat Milk Propylparaben Centella Asiatica Soybean Glycyrrhiza Glabra Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-01
Description

Active ingredients: OCTINOXATE 7%, OCTISALATE 4.5%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Indications and Usage

Indication and usage:

Use at the end of your daily skincare regimen.

Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

Description

Active ingredients: OCTINOXATE 7%, OCTISALATE 4.5%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, PROPYLENE GLYCOL, ISOAMYL p-METHOXYCINNAMATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETEARYL ALCOHOL, CETYL ALCOHOL, HYDROXYETHYL UREA, LAVANDULA ANGUSTIFOLIA (LAVENDER) WATER, C14-22 ALCOHOLS, POLYSORBATE 80, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, DIMETHICONE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, C12-20 ALKYL GLUCOSIDE, ISOHEXADECANE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GOAT MILK EXTRACT, TOCOPHERYL ACETATE, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, OCTISALATE 4.5%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

Use at the end of your daily skincare regimen.

Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and Administration (34068-7)

Dosage and administration:

For best results, apply at least 15 to 20 minutes before sun exposure.

Reapply frequently while out in the sun.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation appear.

Section 50565-1 (50565-1)

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients:

WATER, PROPYLENE GLYCOL, ISOAMYL p-METHOXYCINNAMATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETEARYL ALCOHOL, CETYL ALCOHOL, HYDROXYETHYL UREA, LAVANDULA ANGUSTIFOLIA (LAVENDER) WATER, C14-22 ALCOHOLS, POLYSORBATE 80, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, DIMETHICONE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, C12-20 ALKYL GLUCOSIDE, ISOHEXADECANE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GOAT MILK EXTRACT, TOCOPHERYL ACETATE, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, DISODIUM EDTA, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 7%, OCTISALATE 4.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:20.518972 · Updated: 2026-03-14T22:52:50.897919