NDC | 63354-191-54 |
Set ID | 775a4242-9efb-256a-e053-2991aa0ae37a |
Category | HUMAN OTC DRUG LABEL |
Packager | Edgewell Personal Care Brands LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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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: 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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Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Coco-Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, Fragrance, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice.
- Other Information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-191 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) PARAFFIN (UNII: I9O0E3H2ZE) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCO GLUCOSIDE (UNII: ICS790225B) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENETHYL BENZOATE (UNII: 0C143929GK) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) CARBOMER 934 (UNII: Z135WT9208) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPYLPARABEN (UNII: Z8IX2SC1OH) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-191-54 177 g in 1 BOTTLE; Type 0: Not a Combination Product 10/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/05/2018 Labeler - Edgewell Personal Care Brands LLC (151179769)