BANANA BOAT NATURAL REFLECT SUNSCREEN BABY SPF 50- titanium dioxide, zinc oxide lotion

Banana Boat Natural Reflect Sunscreen BABY SPF 50 by

Drug Labeling and Warnings

Banana Boat Natural Reflect Sunscreen BABY SPF 50 by is a Otc medication manufactured, distributed, or labeled by Energizer Personal Care LLC, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BANANA BOAT NATURAL REFLECT SUNSCREEN BABY SPF 50  
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-002
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 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 mL  in 100 mL

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 5) (UNII: 035JKJ76MT)
ISOPROPYL MALEATE (UNII: M86R5J916V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
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: 63354-002-00	118 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/28/2011

Labeler - Energizer Personal Care LLC (021718141)

Registrant - Formulated Solutions, LLC (143266687)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture