Label: BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 63354-410-16
- Packager: Edgewell Personal Care Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 21, 2022
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- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- stop use and ask a doctor
- Keep out of reach of children
- Directions
-
Inactive ingredients
Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.
- Other Information
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-410 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.4 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) COCONUT OIL (UNII: Q9L0O73W7L) GRAPE SEED OIL (UNII: 930MLC8XGG) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SUNFLOWER OIL (UNII: 3W1JG795YI) CORN OIL (UNII: 8470G57WFM) CARROT (UNII: L56Z1JK48B) BANANA (UNII: 4AJZ4765R9) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-410-16 236 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2013 Labeler - Edgewell Personal Care Brands, LLC (151179769)