Label: 5283 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion
- NDC Code(s): 76138-222-01
- Packager: Innovation Specialties
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2023
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Directions
• Apply liberally 15 minutes exposure. • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.
Sun Protection Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses • children under 6 months: Ask a doctor.
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INGREDIENTS AND APPEARANCE
5283 SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76138-222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) LEVOMENOL (UNII: 24WE03BX2T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76138-222-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/31/2023 Labeler - Innovation Specialties (030837314)
