SPL v1
SPL
SPL Set ID 485d31e4-a2a9-8165-e063-6294a90a14fc
Route
TOPICAL
Published
Effective Date 2026-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.05 g) Ethylhexyl Salicylate (0.03 g) Butyl Methoxydibenzoylmethane
Inactive Ingredients
Phenoxyethanol Avena Sativa (oat) Starch Benzoic Acid Polysorbate 60 Butyloctyl Salicylate Jojoba Oil Glycereth-2 Cocoate Sorbitan Isostearate Aloe Barbadensis Leaf Juice Shea Butter Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Oryza Sativa (rice) Bran Ethylhexylglycerin Sodium Benzoate Hordeum Vulgare Whole Rosmarinus Officinalis (rosemary) Leaf Oil Pentylene Glycol Tocopherol C12-15 Alkyl Benzoate Hydrated Silica Ethyl Ferulate Water Citric Acid Helianthus Annuus (sunflower) Seed Oil Glycerin Cetearyl Alcohol Potassium Sorbate Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-14


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)