BANANA BOAT PROTECTIVE DRY SPF 10- homosalate and octisalate and octocrylene and avobenzone oil

Banana Boat Protective Dry SPF 10 by

Drug Labeling and Warnings

Banana Boat Protective Dry SPF 10 by is a Otc medication manufactured, distributed, or labeled by Accra-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredients:

Homosalate 0.06mL / 1mL

Octisalate 0.06mL / 1mL

Octocrylene 0.025mL / 1mL

Avobenzone 0.015mL / 1mL

DIRECTIONS:

Apply generously and evenly to all areas 20 minutes before sun exposure. No need to rub in. Reapply frequently to maintain protection and also after swimming and towel drying. Do not spray directly on face. Spray on hands to apply to face. Use in a well-ventilated area. For external use only. Avoid contact with eyes and clothes.

USAGE ADVICE:

Do not stay too long in the sun even while using a sun protection product. Keep babies and young children out of direct sunlight. Use clothing and sun protection products with a very high SPF (higher than 25) for babies and young children. Over exposure to the sun is a serious health threat. Reducing applied quantity will significantly lower the level of protection.

WARNING:

FLAMMABLE. Pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50ºC. Do not pierce or burn, even after use. Do not spray on a naked flame, onto or near fire, or any incandescent material. Keep away from sources of ignition – no smoking. Use only as directed. Keep out of reach of children.

INGREDIENTS:

Alcohol Denat., Homosalate, Ethylhexyl Salicylate, Paraffinum liquidum, Diethylhexyl 2, 6-Naphthalate, Octocrylene, Butyl Methoxydibenzoylmethane,Vitis vinifera, Cocos nucifera, Caprylyl Glycol, Acrylates/ Octylacrylamide Copolymer, Aloe barbadensis, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Parfum.

FLAMMABLE
MADE IN U.S.A
DISTRIBUTED BY:
ENERGIZER GROUP LTD
SWORD HOUSE, HP13 6DG
HIGH WYCOMBE, UK
www.bananaboat.co.uk

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
PROTECTIVE
DRY OIL
Continuous Spray Sun Protection
SPF 10 UVA
AvoTriplexTM
Low Protection
Sun-Tested, Sun-ProvenTM
Fast & Even Coverage
Coconut & Grape Seed Oils
Very Water Resistant
175 ml

INGREDIENTS AND APPEARANCE

BANANA BOAT PROTECTIVE DRY SPF 10 
homosalate and octisalate and octocrylene and avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.06 mL  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.06 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.025 mL  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.015 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2012-1	175 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/01/2009

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE