NDC | 63354-170-34, 63354-170-36, 63354-170-37 |
Set ID | 39917955-ce42-1c60-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
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Warnings
For external use only
Flammability: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or
store at temperatures above 120ºF. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. - Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
•Hold container 4 to 6 inches from the skin to apply •Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face. •Do not apply in windy conditions •Use in a well-ventilated area •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
Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, Lauryl PEG-8 Dimethicone,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Ascorbyl Palmitate,Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract
- Other Information
- Questions or Comments?
- PDP
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone homosalate octocrylene aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-170 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g Inactive Ingredients Ingredient Name Strength DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ASCORBYL PALMITATE (UNII: QN83US2B0N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MINERAL OIL (UNII: T5L8T28FGP) ISODODECANE (UNII: A8289P68Y2) ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) PANTHENOL (UNII: WV9CM0O67Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-170-34 170 g in 1 CAN; Type 0: Not a Combination Product 10/01/2015 2 NDC:63354-170-36 227 g in 1 CAN; Type 0: Not a Combination Product 10/01/2015 3 NDC:63354-170-37 269 g in 1 CAN; Type 0: Not a Combination Product 10/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2015 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations Playtex Manufacturing, Inc 963501502 manufacture(63354-170)