Label: BANANA BOAT- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 63354-050-26, 63354-050-27 - Packager: Energizer Personal Care LLC
- Category: HUMAN PRESCRIPTION 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 October 3, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
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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, regulatory 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
- Other information
- Questions or Comments?
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Principal Display Panel
Banana Boat
Baby
Tear Free Sting Free
UVA/UVB Protection
Sunscreen Lotion
50
Broad Spectrum SPF 50
Pediatrician Tested
Proven to be Gentle
Water Resistant (80 minutes)
Recommended Skin Cancer Foundation
Active
Recommended as an effective UV sunscreen
Swim Splash Play
8 FL. OZ. (236 mL)
Bonus 25% More
Banana Boat
Baby
Tear Free Sting Free
UVA/UVB Protection
Sunscreen Lotion
50
Broad Spectrum SPF 50
Pediatrician Tested
Proven to be Gentle
Water Resistant (80 minutes)
Recommended Skin Cancer Foundation
Active
Recommended as an effective UV sunscreen
Swim Splash Play
10 FL. OZ. (295 mL)
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INGREDIENTS AND APPEARANCE
BANANA BOAT
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63354-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.1 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOHEXADECANE (UNII: 918X1OUF1E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-050-26 236 g in 1 TUBE 2 NDC:63354-050-27 295 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/03/2012 Labeler - Energizer Personal Care LLC (021718141)