NDC | 63354-923-34 |
Set ID | 617df26b-699b-5d6c-e053-2a91aa0a045b |
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
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.
- 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 •Children under 6 months: Ask a doctor
- Inactive Ingredients
- Other Information
- Questions or Comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-923 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SODIUM CITRATE (UNII: 1Q73Q2JULR) ISOBUTANE (UNII: BXR49TP611) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOHEXADECANE (UNII: 918X1OUF1E) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-923-34 170 g in 1 CAN; Type 0: Not a Combination Product 01/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2018 Labeler - Edgewell Personal Care Brands LLC (151179769) Establishment Name Address ID/FEI Business Operations KIK Custom Product 243547333 manufacture(63354-923)