Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fa16d89e-9fa0-482d-8185-52bb8b33038d
Route
CUTANEOUS
Published
Effective Date 2011-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.9 mL) Octisalate (3.5 mL) Titanium (0.65 mL)
Inactive Ingredients
Water Butylene Glycol Propylene Glycol Arbutin C14-22 Alcohols Cyclomethicone 5 Silicon Dioxide Sorbitan Monostearate C12-20 Alkyl Glucoside Phenoxyethanol Cucumber Methylparaben Aloe Vera Leaf Isohexadecane Polysorbate 80 Potassium Cetyl Phosphate Propylparaben Aluminum Hydroxide Stearic Acid Butylated Hydroxytoluene Edetate Disodium

Identifiers & Packaging

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

Active ingredients: OCTINOXATE 7%, OCTISALATE 5%, TITANIUM DIOXIDE 0.93%

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 5%, TITANIUM DIOXIDE 0.93%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 7%, OCTISALATE 5%, TITANIUM DIOXIDE 0.93%

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, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

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 5%, TITANIUM DIOXIDE 0.93%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:20.525159 · Updated: 2026-03-14T22:52:50.897919