Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a1f76361-23fa-4ef8-96d6-eaf3a6b6540c
Route
CUTANEOUS
Published
Effective Date 2011-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7 mL) Ensulizole (2 mL)
Inactive Ingredients
Water Enzacamene Alkyl (c12-15) Benzoate Butylene Glycol Bemotrizinol Medium-chain Triglycerides Aloe Vera Leaf C12-20 Alkyl Glucoside C14-22 Alcohols Dimethicone Glycerin Methylparaben Sodium Hydroxide Carboxymethylcellulose Sodium Cetearyl Olivate Sorbitan Olivate Propylparaben Edetate Disodium Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

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

Active ingredients: OCTINOXATE 7%, ENSULIZOLE 2%

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%, ENSULIZOLE 2%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, ENSULIZOLE 2%

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, C12-15 ALKYL BENZOATE, 4-METHYLBENZYLIDENE CAMPHOR, BUTYLENE GLYCOL, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARETH-6 OLIVATE, PEG-7 GLYCERYL COCOATE, ALOE BARBADENSIS LEAF EXTRACT, C12-20 ALKYL GLUCOSIDE, C14-22 ALCOHOLS, DIMETHICONE, MALPIGHIA GLABRA(ACEROLA) FRUIT EXTRACT, GLYCERIN, SODIUM HYDROXIDE, CELLULOSE GUM, CETEARYL OLIVATE, SORBITAN OLIVATE, MICROCRYSTALLINE CELLULOSE, DISODIUM EDTA, ETHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, 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%, ENSULIZOLE 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:20.349299 · Updated: 2026-03-14T22:52:50.897919