NDC | 63354-788-31, 63354-788-34, 63354-788-36, 63354-788-37 |
Set ID | 441cda3e-91f1-2877-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 dcotor
- Keep out of reach of children
-
flammable
Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. 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.
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Directions
- Shake well.
- 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
- 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, Isobutane, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone,Lauryl PEG-8 Dimethicone, Dibutyl Adipate, Ethylhexyl Methoxycrylene, Sodium Chloride,PEG-8, Phenoxyethanol, Caprylyl Glycol, Glycerin, Sodium Citrate, Methylparaben,Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methyl Dihydroabietate,Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.
- Other Information
- Questions or Comments?
- Front Label
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-788 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 6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ISOBUTANE (UNII: BXR49TP611) ISOHEXADECANE (UNII: 918X1OUF1E) DIBUTYL ADIPATE (UNII: F4K100DXP3) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) PEG-8 DIMETHICONE (UNII: GIA7T764OD) OCTYLDODECANOL (UNII: 461N1O614Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ASCORBIC ACID (UNII: PQ6CK8PD0R) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) ETHYL BENZOATE (UNII: J115BRJ15H) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-788-31 51 g in 1 CAN; Type 0: Not a Combination Product 01/02/2017 2 NDC:63354-788-34 170 g in 1 CAN; Type 0: Not a Combination Product 01/02/2017 3 NDC:63354-788-36 227 g in 1 CAN; Type 0: Not a Combination Product 01/02/2017 4 NDC:63354-788-37 269 g in 1 CAN; Type 0: Not a Combination Product 11/01/2017 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)