Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ede17cd9-02be-4ed4-aaf9-cb85afc547fb
Route
CUTANEOUS
Published
Effective Date 2011-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3 g) Octisalate (2.5 g) Titanium (1.7 g) Avobenzone (0.75 g)
Inactive Ingredients
Water Propylene Glycol Isopropyl Myristate Cetyl Alcohol Polysorbate 80 Diethylhexyl Carbonate Potassium Cetyl Phosphate Glyceryl Monostearate Peg-100 Stearate Caprylyl Glycol Isohexadecane Aluminum Hydroxide Stearic Acid Glycerin Pinus Palustris Pollen Carrot Trimethoxycaprylylsilane Butylated Hydroxytoluene Edetate Disodium Chamomile Flower Oil Bergamot Oil Citrus Sinensis Flower Oil Citrus Limon Fruit Oil Fennel Oil Lavender Oil Rosemary Oil Starch, Corn

Identifiers & Packaging

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

Active ingredients: OCTINOXATE 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

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:

After your daily skincare regimen, apply liberally onto your face, neck, arms, legs, and other areas that are easily exposed to UV sunlight. Avoid 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 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

Section 50565-1

Keep out of reach of children:

Keep out of reach of children.

Section 51727-6

Inactive ingredients:

WATER, PROPYLENE GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ISOAMYL p-METHOXYCINNAMATE, ISOPROPYL MYRISTATE, CETYL ALCOHOL, POLYSORBATE 80, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, ALUMINUM HYDROXIDE, STEARIC ACID, BAMBUSA TEXTILIS STEM EXTRACT, BETA-GLUCAN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, GLYCERIN, PINUS PALUSTRIS LEAF EXTRACT, TRIDECETH-6, ETHYLHEXYL STEARATE, SODIUM POLYACRYLATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TRIMETHOXYCAPRYLYLSILANE, BHT, DISODIUM EDTA, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, FOENICULUM VULGARE (FENNEL) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, ZEA MAYS (CORN) OIL

Section 51945-4

Section 55105-1

Purpose: Protects skin from UV rays.

Section 55106-9

Active ingredients: OCTINOXATE 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

After your daily skincare regimen, apply liberally onto your face, neck, arms, legs, and other areas that are easily exposed to UV sunlight. Avoid 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, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ISOAMYL p-METHOXYCINNAMATE, ISOPROPYL MYRISTATE, CETYL ALCOHOL, POLYSORBATE 80, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE, PEG-100 STEARATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, ALUMINUM HYDROXIDE, STEARIC ACID, BAMBUSA TEXTILIS STEM EXTRACT, BETA-GLUCAN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, GLYCERIN, PINUS PALUSTRIS LEAF EXTRACT, TRIDECETH-6, ETHYLHEXYL STEARATE, SODIUM POLYACRYLATE, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TRIMETHOXYCAPRYLYLSILANE, BHT, DISODIUM EDTA, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, FOENICULUM VULGARE (FENNEL) OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, ZEA MAYS (CORN) OIL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Protects skin from UV rays.

Section 55106-9 (55106-9)

Active ingredients: OCTINOXATE 6%, OCTISALATE 5%, TITANIUM DIOXIDE 3.4%, AVOBENZONE 1.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.626499 · Updated: 2026-03-14T22:52:49.153069