Banana Boat Natural Reflect Sunscreen BABY SPF 50

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 3.1mL in 100mL, ZINC OXIDE 4mL in 100mL
Labeler: Energizer Personal Care LLC
NDC Code: 63354-002

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.

Banana Boat Natural Reflect Sunscreen Lotion BABY SPF 50

Protect your baby’s soft and precious skin with an effective yet gentle and more natural sunscreen with Banana Boat® Lotion Natural Reflect Baby SPF 50. Massage this ultra-gentle formula on baby’s skin for clinically proven protection. Tear-Free and Sting-Free to eyes, it does not contain harsh chemical sunscreens because it is formulated with 100% naturally-sourced sunscreen actives. Pediatrician-tested, this formula works by forming a protective layer on skin that reflects UVA and UVB rays.
• Oxybenzone-Free • Non-Stinging to Eyes
• Water Resistant (80 minutes
)

Drug Facts


Active Ingredients

Titanium Dioxide 3.1%, Zinc Oxide 4.0%

Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections 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 product is 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, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time on the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients:

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride,
Ethylhexyl Methoxycrylene, Dimethicone, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol

Other Information
  • protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

The Skin Cancer Foundation recommends this product as an effective UV sunscreen.

www.bananaboat.com

MADE IN U.S.A.

Dist. By:

ENERGIZER PERSONAL CARE, LLC

SHELTON, CT 06484

2011 Sun Pharmaceuticals, LLC

Banana Boat Natural Reflect Sunscreen Lotion BABY SPF 50

NEW!

BANANA BOAT

natural

reflect

sunscreen lotion

BABY

Tear-Free

Sting-Free

UVA/UVB PROTECTION

50

BROAD SPECTRUM SPF 50

100% Naturally Sourced Sunscreens with Zinc Oxide

Proven Effective Against Sunburn and Long-Term Damage

Paraben and PABA Free

Water Resistant (80 Minutes)

SWIM * SPLASH * SPORT

4 FL. OZ. (118 ml)

RECOMMENDED

SKIN CANCER FOUNDATION

ACTIVE


BANANA BOAT NATURAL REFLECT SUNSCREEN BABY SPF 50  
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.1 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
ISOHEXADECANE 
BUTYLOCTYL SALICYLATE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
ISOPROPYL MALEATE 
SODIUM CHLORIDE 
DIMETHICONE 
CAPRYLYL GLYCOL 
POLYETHYLENE GLYCOL 400 
ALUMINUM OXIDE 
GLYCERIN 
SODIUM CITRATE 
ALPHA-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:63354-002-00118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/28/2011
Labeler - Energizer Personal Care LLC (021718141)
Registrant - Formulated Solutions, LLC (143266687)
Establishment
NameAddressID/FEIOperations
Formulated Solutions, LLC143266687manufacture

Revised: 12/2011
 
Energizer Personal Care LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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