Label: BANANA BOAT KIDS TEAR FREE CONTINUOUS SPF 50- avobenzone and homosalate and octinoxate and octisalate and octocrylene spray
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Contains inactivated NDC Code(s)
NDC Code(s): 17630-2004-1, 17630-2004-2 - 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 18, 2010
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other Information
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Inactive Ingredients
Isobutane, Water, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Glycol, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Tocopheryl Acetate (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Sodium Citrate, Sodium Chloride, Aloe Barbadensis (Aloe Vera) Leaf Juice, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Disodium EDTA
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INGREDIENTS AND APPEARANCE
BANANA BOAT KIDS TEAR FREE CONTINUOUS SPF 50
avobenzone and homosalate and octinoxate and octisalate and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.15 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2004-1 170 g in 1 CAN 2 NDC:17630-2004-2 226 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/22/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE