NDC | 63354-388-61 |
Set ID | 616d35a1-a139-1974-e053-2a91aa0a20b6 |
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
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
-
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
- 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 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 sleeve shirts, pants, hats and sunglasses
- children under 6 months: Ask a doctor.
-
Inactive Ingredients
Ozokerite, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Adipate, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, PEG-8, Caprylyl Glycol, Silica, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer.
- Other Information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-388 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.7 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O) COCOA BUTTER (UNII: 512OYT1CRR) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S) CETYL ALCOHOL (UNII: 936JST6JCN) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CERESIN (UNII: Q1LS2UJO3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-388-61 42.5 g in 1 TUBE; 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)