NDC | 63354-328-21, 63354-328-26, 63354-328-27, 63354-328-38 |
Set ID | 4442b919-c310-62f0-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
- 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
•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.
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Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Isohexadecane,Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone,Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.
- Other Information
- Questions or Comments?
- Front Label
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INGREDIENTS AND APPEARANCE
BANANA BOAT
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-328 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.5 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) WATER (UNII: 059QF0KO0R) ISOHEXADECANE (UNII: 918X1OUF1E) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM OXIDE (UNII: LMI26O6933) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-328-21 59 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2017 2 NDC:63354-328-26 236 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2017 3 NDC:63354-328-27 295 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2017 4 NDC:63354-328-38 354 g in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2017 Labeler - Edgewell Personal Care Brands LLC (151179769)