Home SPL Set DailyMed SPL v1 SPL SPL Set ID 48dd7f6e-2a4d-2c92-e063-6294a90a4255 Route CUTANEOUS Published Effective Date 2026-01-21 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Octocrylene (1 g) Homosalate Titanium Dioxide Avobenzone Ensulizole Inactive Ingredients Propanediol Triethanolamine C12-20 Alkyl Glucoside Glycerin 2-bromo-4'-hydroxyacetophenone Sorbitan Isostearate Citric Acid Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ethylhexyl Stearate Fragrance 13576 Dibutyl Adipate Potassium Cetyl Phosphate Peg-100 Stearate Cetyl Ethylhexanoate Calcium Disodium Edta Disodium Alpha-tocopheryl Phosphate, Dl- Butylene Glycol Allantoin Glyceryl Stearate Xanthan Gum Water Dipropylene Glycol C14-22 Alcohols 1,2-hexanediol Sodium Hydroxide Polysorbate 60 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Identifiers & Packaging Marketing Status OTC MONOGRAPH DRUG Active Since 2026-01-21 Description HOMOSALATE,OCTOCRYLENE,AVOBENZONE,ENSULIZOLE,TITANIUM DIOXIDE Medication Information Warnings and Precautions keep out reach of children Indications and Usage Apply to the palms, rub onto the skin, used for sun protection Dosage and Administration Apply to the palms, rub onto the skin, used for sun protection Description HOMOSALATE,OCTOCRYLENE,AVOBENZONE,ENSULIZOLE,TITANIUM DIOXIDE Section 50565-1 keep out of reach of children section Section 51727-6 WATER,CETYL ETHYLHEXANOATE,ETHYLHEXYL STEARATE,GLYCERIN,DIBUTYL ADIPATE,DIPROPYLENE GLYCOL Section 51945-4 Section 55105-1 Sunscreen Section 55106-9 HOMOSALATE,OCTOCRYLENE,AVOBENZONE,ENSULIZOLE,TITANIUM DIOXIDE Structured Label Content Indications and Usage (34067-9) Apply to the palms, rub onto the skin, used for sun protection Dosage and Administration (34068-7) Apply to the palms, rub onto the skin, used for sun protection Warnings and Precautions (34071-1) keep out reach of children Section 50565-1 (50565-1) keep out of reach of children section Section 51727-6 (51727-6) WATER,CETYL ETHYLHEXANOATE,ETHYLHEXYL STEARATE,GLYCERIN,DIBUTYL ADIPATE,DIPROPYLENE GLYCOL Section 51945-4 (51945-4) Section 55105-1 (55105-1) Sunscreen Section 55106-9 (55106-9) HOMOSALATE,OCTOCRYLENE,AVOBENZONE,ENSULIZOLE,TITANIUM DIOXIDE Advanced Ingredient Data [{"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-20 ALKYL GLUCOSIDE", "unii": "K67N5Z1RUA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "2-BROMO-4'-HYDROXYACETOPHENONE", "unii": "6H0QU4I6BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN ISOSTEARATE", "unii": "01S2G2C1E4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL STEARATE", "unii": "EG3PA2K3K5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBUTYL ADIPATE", "unii": "F4K100DXP3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CETYL PHOSPHATE", "unii": "03KCY6P7UT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ETHYLHEXANOATE", "unii": "134647WMX4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM DISODIUM EDTA", "unii": "8U5D034955", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM ALPHA-TOCOPHERYL PHOSPHATE, DL-", "unii": "35ZC9LRM4U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ENSULIZOLE", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPROPYLENE GLYCOL", "unii": "E107L85C40", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C14-22 ALCOHOLS", "unii": "B1K89384RJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)", "unii": "86FQE96TZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"34067-9": "Apply to the palms, rub onto the skin, used for sun protection", "34068-7": "Apply to the palms, rub onto the skin, used for sun protection", "34071-1": "keep out reach of children", "50565-1": "keep out of reach of children section", "51727-6": "WATER,CETYL ETHYLHEXANOATE,ETHYLHEXYL STEARATE,GLYCERIN,DIBUTYL ADIPATE,DIPROPYLENE GLYCOL", "55105-1": "Sunscreen", "55106-9": "HOMOSALATE,OCTOCRYLENE,AVOBENZONE,ENSULIZOLE,TITANIUM DIOXIDE"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:08:19.370398 · Updated: 2026-03-14T23:12:31.383435
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