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Banana Boat Sunscreen

Generic Name: titanium dioxide, zinc oxide
Dosage Form: lotion

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 Facts

Active Ingredients

Titanium Dioxide 3.1%
Zinc Oxide 4.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed wiht other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

  • For external use only
  • Do not use on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics.

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

  • protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

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)

BANANA BOAT 
titanium dioxide, zinc oxide lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63354-050
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.1 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
MEDIUM-CHAIN TRIGLYCERIDES  
ISOHEXADECANE  
BUTYLOCTYL SALICYLATE  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)  
SODIUM CHLORIDE  
ETHYLHEXYL METHOXYCRYLENE  
DIMETHICONE  
CAPRYLYL GLYCOL  
POLYETHYLENE GLYCOL 400  
ALUMINUM OXIDE  
GLYCERIN  
SODIUM CITRATE  
.ALPHA.-TOCOPHEROL ACETATE  
ALOE VERA LEAF  
PHENOXYETHANOL  
Packaging
# Item Code Package Description
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)
Revised: 10/2012
 
Energizer Personal Care LLC



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