Label: BANANA BOAT PROTECTIVE DRY SPF 10- homosalate and octisalate and octocrylene and avobenzone oil
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Contains inactivated NDC Code(s)
NDC Code(s): 17630-2012-1 - Packager: Accra-Pac, Inc.
- Category: HUMAN OTC DRUG LABEL
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 25, 2010
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- 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 frequently to maintain protection and also 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 and clothes.
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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.
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WARNING:
FLAMMABLE. Pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Do not spray on a naked flame, onto or near fire, or any incandescent material. Keep away from sources of ignition – no smoking. Use only as directed. Keep out of reach of children.
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INGREDIENTS:
Alcohol Denat., Homosalate, Ethylhexyl Salicylate, Paraffinum liquidum, Diethylhexyl 2, 6-Naphthalate, Octocrylene, Butyl Methoxydibenzoylmethane,Vitis vinifera, Cocos nucifera, Caprylyl Glycol, Acrylates/ Octylacrylamide Copolymer, Aloe barbadensis, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Parfum.
FLAMMABLE
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 PROTECTIVE DRY SPF 10
homosalate and octisalate and octocrylene and avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.06 mL in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.06 mL in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.025 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.015 mL in 1 mL Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) GRAPE SEED OIL (UNII: 930MLC8XGG) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2012-1 175 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/01/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE
