Label: BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30- avobenzone,homosalate,octisalate,octocrylene lotion
- NDC Code(s): 63354-159-23
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 1, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
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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 • Sun Protection Measures. Spendi ng 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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Inactive Ingredients
Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glycerin, Ascorbyl Glucoside, Chlorphenesin, Dicetyl Phosphate, Ceteth10 Phosphate, Coco Glucoside,
Sodium Hydroxide, Propylene Glycol, Cocos Nucifera (Coconut) Oil, Xanthan Gum, Disodium EDTA, Camellia Sinensis Leaf Extract, Fragrance, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides - Other Information
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INGREDIENTS AND APPEARANCE
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30
avobenzone,homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) NIACINAMIDE (UNII: 25X51I8RD4) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) COCO GLUCOSIDE (UNII: ICS790225B) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCONUT OIL (UNII: Q9L0O73W7L) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MICA (UNII: V8A1AW0880) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-159-23 133 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2022 Labeler - Edgewell Personal Care Brands LLC (151179769)
