NDC | 63354-078-34, 63354-078-35, 63354-078-36, 63354-078-37 |
Set ID | 767a1504-1e02-1e06-e053-2a91aa0aa4b6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Edgewell Personal Care Brands LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredient
- Purpose
- Uses
- Warnings
- Flammable
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- May stain
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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 then apply to face. Do not apply in windy conditions. Use in 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 - 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:63354-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOBUTANE (UNII: BXR49TP611) ISODODECANE (UNII: A8289P68Y2) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-078-34 170 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 2 NDC:63354-078-37 269 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 3 NDC:63354-078-36 227 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 4 NDC:63354-078-35 212 g in 1 CAN; Type 0: Not a Combination Product 10/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/15/2018 Labeler - Edgewell Personal Care Brands LLC (151179769)