SPL v1
SPL
SPL Set ID cc86eead-7c6c-71e1-e053-2995a90ad1ef
Route
TOPICAL
Published
Effective Date 2021-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.05 g) Avobenzone (0.03 g) Homosalate (0.065 g) Oxybenzone (0.02 g) Octinoxate (0.075 g)
Inactive Ingredients
Xanthan Gum Butyloctyl Salicylate Cetostearyl Alcohol Cetearyl Olivate Edetate Disodium Ethylhexyl Palmitate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Water Glycerin Phenoxyethanol Ethylhexylglycerin Rice Bran Rosemary Tocopherol Caprylyl Glycol Helianthus Annuus Flowering Top Glyceryl 1-stearate Menthyl Lactate, (-)- Sorbitan Olivate Eicosyl Povidone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-09-21

Medication Information

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Structured Label Content

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:44.965353 · Updated: 2026-03-14T22:59:48.053698