Label: BANANA BOAT SPORT SPF 30- homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone spray
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Contains inactivated NDC Code(s)
NDC Code(s): 17630-2021-1 - Packager: Accra-Pac, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 26, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
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DIRECTIONS:
Apply generously and evenly to all areas 20 minutes before sun exposure. No need to rub in. Reapply at frequent intervals, after swimming and towel drying. Do not spray directly on face. Spray on hands to apply to face. Use in a well-ventilated area.
For external use only.
Avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation or rash appears, discontinue use. May stain some fabrics.
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USAGE ADVICE:
Do not stay too long in the sun even while using a sun protection product. Keep babies and young children out of direct sunlight. Use clothing and sun protection products with a very high spf (higher than 25) for babies and young children. Over exposure to the sun is a serious health threat. Reducing applied quantity will significantly lower the level of protection.
- WARNING:
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INGREDIENTS:
Alcohol Denat., Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Benzophenone-3, Butyl Methoxydibenzoylmethane, Octocrylene, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe barbadensis, Retinyl Palmitate, Dimethyl Capramide, Tocopherol, Parfum, Alpha-isomethyl Ionone, Amyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Limonene, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl 3-cyclohexene Carboxaldehyde, Linalool.
Contains Oxybenzone.
MADE IN U.S.A
DISTRIBUTED BY:
ENERGIZER GROUP LTD
SWORD HOUSE, HP13 6DG
HIGH WYCOMBE, UK
www.bananaboat.co.uk - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANANA BOAT SPORT SPF 30
homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.0878 mL in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.05 mL in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 mL in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.025 mL in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.05 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 mL in 1 mL Inactive Ingredients Ingredient Name Strength C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) AMYL CINNAMAL (UNII: WC51CA3418) BENZYL BENZOATE (UNII: N863NB338G) GERANIOL (UNII: L837108USY) ALOE VERA LEAF (UNII: ZY81Z83H0X) LIMONENE, DL- (UNII: 9MC3I34447) LINALOOL, DL- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2021-1 175 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/09/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE
