Label: HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30- avobenzone,octisalate,octocrylene stick
- NDC Code(s): 63354-520-61
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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Directions
• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: Ask a doctor. •Sun Protection Measures. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses. •Children under 6 months: Ask a doctor
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INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30
avobenzone,octisalate,octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-520 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PETROLATUM (UNII: 4T6H12BN9U) CERESIN (UNII: Q1LS2UJO3A) ETHYLHEXYL PALMITATE (UNII: 2865993309) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) RICE BRAN (UNII: R60QEP13IC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-520-61 4.25 g in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/01/2021 Labeler - Edgewell Personal Care Brands LLC (151179769)