SPL v1
SPL
SPL Set ID 319e8e26-b299-4627-e063-6294a90acfba
Route
TOPICAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol (0.438 mg)
Inactive Ingredients
Tridecyl Trimellitate Ethylhexyl Palmitate Ethylhexyl Methoxycinnamate Octocrylene Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Aloe Barbadensis Leaf Caprylyl Glycol Niacinamide Ceresin Synthetic Wax (540 Mw) Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Acetyl Hexapeptide-8 Caprylic/capric Triglyceride Diethylhexyl Butamido Triazone Ci 19140 Ethylhexyl Salicylate Water Phenoxyethanol Copper Tripeptide-1 Dicaprylyl Carbonate Isododecane Silica Dimethyl Silylate Bht Fragrance Lemon Orc2001060 Microcrystalline Wax Butylene Glycol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31

Description

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps prevent sunbum.

lf used as directed with other sun protectionmeasures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Apply liberally/generously (and evenly) 15 minutes before sun exposure

For use on children less than 6 months of age, consult a health care practitioner

Reapply

At least every 2 hours

After 80 minutes of swimming or sweating

Immediately after towel drying

Description

Sunscreen

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help orcontact Poison Control Center right away

Section 51727-6

ETHYLHEXYL PALMITATE

MICROCRYSTALLINE WAX

CAPRYLIC/CAPRIC TRIGLYCERIDE

OZOKERITE

ETHYLHEXYL SALICYLATE

SYNTHETIC WAX

DICAPRYLYL CARBONATE

DIETHYLHEXYL BUTAMIDO TRIAZONE

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE

ISODODECANE

ETHYLHEXYL METHOXYCINNAMATE

BHT

OCTOCRYLENE

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

SILICA DIMETHYL SILYLATE

FRAGRANCE

TRIDECYL TRIMELLITATE

CI 19140

WATER

BUTYLENE GLYCOL

ALOE BARBADENSIS LEAF EXTRACT

PHENOXYETHANOL

WATER

CAPRYLYL GLYCOL

ACETYL HEXAPEPTIDE-8

COPPER TRIPEPTIDE-1

NIACINAMIDE

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

TOCOPHERYL ACETATE -----0.438%


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunbum.

lf used as directed with other sun protectionmeasures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Apply liberally/generously (and evenly) 15 minutes before sun exposure

For use on children less than 6 months of age, consult a health care practitioner

Reapply

At least every 2 hours

After 80 minutes of swimming or sweating

Immediately after towel drying

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help orcontact Poison Control Center right away

Section 51727-6 (51727-6)

ETHYLHEXYL PALMITATE

MICROCRYSTALLINE WAX

CAPRYLIC/CAPRIC TRIGLYCERIDE

OZOKERITE

ETHYLHEXYL SALICYLATE

SYNTHETIC WAX

DICAPRYLYL CARBONATE

DIETHYLHEXYL BUTAMIDO TRIAZONE

BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE

ISODODECANE

ETHYLHEXYL METHOXYCINNAMATE

BHT

OCTOCRYLENE

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

SILICA DIMETHYL SILYLATE

FRAGRANCE

TRIDECYL TRIMELLITATE

CI 19140

WATER

BUTYLENE GLYCOL

ALOE BARBADENSIS LEAF EXTRACT

PHENOXYETHANOL

WATER

CAPRYLYL GLYCOL

ACETYL HEXAPEPTIDE-8

COPPER TRIPEPTIDE-1

NIACINAMIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

TOCOPHERYL ACETATE -----0.438%


Advanced Ingredient Data


Raw Label Data

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