SPL v1
SPL
SPL Set ID 3f605561-e310-5bdb-e063-6394a90a28a8
Route
TOPICAL
Published
Effective Date 2025-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3 mg) Methylene Bis-benzotriazolyl Tetramethylbutylphenol (0.75 mg) Ethylhexyl Methoxycinnamate (5.9958 mg) 4-methylbenzylidene Camphor (2 mg) Phenylbenzimidazole Sulfonic Acid (1 mg) Honey (0.001 mg) Saccharomyces Lysate (0.00885 mg) Hydrolysed Marine Collagen (enzymatic; 2000 Mw) (0.01 mg)
Inactive Ingredients
Sorbitan Oleate Butyrospermum Parkii (shea) Butter Water Cetearyl Alcohol Sodium Acrylate Maltitol Dmdm Hydantoin Methylparaben Alpha-tocopherol Acetate Fragrance Mint Orc2000774 Glycerin Pentylene Glycol Tallow Ethylhexyl Palmitate Mannitol 1,2-hexanediol Allantoin Zinc Oxide Ci 11680 Caprylyl Glycol Sorbitol Bht Decyl Glucoside Sodium Laureth Sulfate Xanthan Gum Potassium Cetyl Phosphate Olea Europaea (olive) Fruit Oil Polysorbate 80 Propylene Glycol 1,2-distearate Hydroxyacetophenone Dimethicone Phenoxyethanol Isohexadecane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-22

Description

DIRECTIONS: - Apply liberally 15 minutes before sun exposure - Reapply at least every 2 hours - Use a water resistant sunscreen if swimming or sweating - Children under 6 months of age: ask a doctor


Medication Information

Warnings and Precautions

WARNINGS:

- For external use only.

Indications and Usage

USES:

- Helps prevent sunburn.

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- Children under 6 months of age: ask a doctor

Description

DIRECTIONS: - Apply liberally 15 minutes before sun exposure - Reapply at least every 2 hours - Use a water resistant sunscreen if swimming or sweating - Children under 6 months of age: ask a doctor

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

WATER

BHT

GLYCERIN

ETHYLHEXYL PALMITATE

CETEARYL ALCOHOL

SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

ISOHEXADECANE

POLYSORBATE 80

SORBITAN OLEATE

DECYL GLUCOSIDE

PROPYLENE GLYCOL

XANTHAN GUM

POTASSIUM CETYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

SORBITOL

MANNITOL

MALTITOL

DIMETHICONE

DMDM HYDANTOIN

ALLANTOIN

METHYLPARABEN

BUTYROSPERMUM PARKII (SHEA) BUTTER

FRAGRANCE

HYDROXYACETOPHENONE

PENTYLENE GLYCOL

1,2-HEXANEDIOL

TOCOPHERYL ACETATE

OLEA EUROPAEA (OLIVE) FRUIT OIL

TALLOW

ZINC OXIDE

CI 11680

SODIUM LAURETH SULFATE

PHENOXYETHANOL

CAPRYLYL GLYCOL

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

ETHYLHEXYL METHOXYCINNAMATE

OCTOCRYLENE

4-METHYLBENZYLIDENE CAMPHOR

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

PHENYLBENZIMIDAZOLE SULFONIC ACID

SACCHAROMYCES FERMENT FILTRATE

HONEY EXTRACT

HYDROLYZED COLLAGEN


Structured Label Content

Indications and Usage (34067-9)

USES:

- Helps prevent sunburn.

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- Children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

WARNINGS:

- For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

WATER

BHT

GLYCERIN

ETHYLHEXYL PALMITATE

CETEARYL ALCOHOL

SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

ISOHEXADECANE

POLYSORBATE 80

SORBITAN OLEATE

DECYL GLUCOSIDE

PROPYLENE GLYCOL

XANTHAN GUM

POTASSIUM CETYL PHOSPHATE

DIPOTASSIUM PHOSPHATE

SORBITOL

MANNITOL

MALTITOL

DIMETHICONE

DMDM HYDANTOIN

ALLANTOIN

METHYLPARABEN

BUTYROSPERMUM PARKII (SHEA) BUTTER

FRAGRANCE

HYDROXYACETOPHENONE

PENTYLENE GLYCOL

1,2-HEXANEDIOL

TOCOPHERYL ACETATE

OLEA EUROPAEA (OLIVE) FRUIT OIL

TALLOW

ZINC OXIDE

CI 11680

SODIUM LAURETH SULFATE

PHENOXYETHANOL

CAPRYLYL GLYCOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

ETHYLHEXYL METHOXYCINNAMATE

OCTOCRYLENE

4-METHYLBENZYLIDENE CAMPHOR

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

PHENYLBENZIMIDAZOLE SULFONIC ACID

SACCHAROMYCES FERMENT FILTRATE

HONEY EXTRACT

HYDROLYZED COLLAGEN


Advanced Ingredient Data


Raw Label Data

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