NDC | 63354-795-21, 63354-795-54, 63354-795-56 |
Set ID | 283388e7-b5c7-6c45-e054-00144ff88e88 |
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
For External Use only.
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.
- D o not use
- When using this product
- Stop use and ask a doctor
- keep out of reach of children
- OTHER SAFETY INFORMATION
- Directions
-
Inactive ingredients
Water, Ethylhexyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Fragrance, Coco- Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice.
- Other Information
- Questions or comments?
- PDP
-
INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone homosalate octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-795 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 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE 350 (UNII: 2Y53S6ATLU) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 934 (UNII: Z135WT9208) COCO GLUCOSIDE (UNII: ICS790225B) METHYLPARABEN (UNII: A2I8C7HI9T) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM HYDROXIDE (UNII: 55X04QC32I) PARAFFIN (UNII: I9O0E3H2ZE) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENETHYL BENZOATE (UNII: 0C143929GK) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) PANTHENOL (UNII: WV9CM0O67Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-795-21 29 g in 1 TUBE; Type 0: Not a Combination Product 10/15/2015 2 NDC:63354-795-54 177 g in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2015 3 NDC:63354-795-56 221 g in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2015 12/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/15/2015 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations Playtex Manufacturing Inc. 963501502 manufacture(63354-795)