485d31e4-a2a9-8165-e063-6294a90a14fc

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

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)