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

Banana Boat Natural Reflect Sunscreen SPF 50 Plus by

Drug Labeling and Warnings

Banana Boat Natural Reflect Sunscreen SPF 50 Plus 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

Banana Boat Lotion Natural Reflect SPF 50+  provides clinically proven protection against sunburn and long-term skin damage without the use of harsh chemical sunscreens because it is formulated with 100% naturally-sourced sunscreen actives. After rubbing in, this rich, more natural mineral sunscreen feels clean on your skin and provides a clear protective layer that reflects UVA and UVB rays. It is Dermatologist-tested and gentle enough for use on sensitive skin.

• Oxybenzone-Free
• Oil-Free
• UVA/UVB Protection
• Leaves no white residue
  

Drug Facts

Active Ingredients

Titanium Dioxide 2.8%, Zinc Oxide 4.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only.

WHEN USING

Avoid contact with eyes. In case of contact rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously and evenly to all areas 15 minutes before sun exposure
• massage in for a clear finish
• reapply at frequent intervals and after swimming or towel drying
• ask a doctor before use on children under six months of age
  

Inactive Ingredients:

Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Ozokerite, Cyclopentasiloxane, Cyclohexasiloxane, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Ethylhexyl Methoxycrylene, PEG-8, Sodium Chloride, Caprylyl Glycol, Dimethicone, Glycerin, Sodium Citrate, Disodium EDTA, Panthenol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice (Aloe Vera), Phenoxyethanol.

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun. May stain some fabrics.

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 SPF 50+

NEW!

BANANA BOAT

natural

reflect

sunscreen lotion

SPF 50+

BROAD SPECTRUM

100% Naturally Sourced Sunscreens with Zinc Oxide

Proven Effective Against Sunburn and Long-Term Damage

Paraben and PABA Free

Very Water Resistant

4 FL. OZ. (118 ml)

RECOMMENDED

SKIN CANCER FOUNDATION

ACTIVE

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-001-00	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