Banana Boat Sport Body And Scalp Spf 30 (Homosalate And Octinoxate And Octisalate And Octocrylene And Oxybenzone And Avobenzone) Lotion [Accra-Pac, Inc.] -

BANANA BOAT SPORT BODY AND SCALP SPF 30 (HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE AND AVOBENZONE) LOTION [ACCRA-PAC, INC.]
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NDC	17630-2020-1
Set ID	224060ac-0d53-4b89-8d32-8d28cff7fe3c
Category	HUMAN OTC DRUG LABEL
Packager	Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION
Active Ingredients

Homosalate 0.0878mL / 1mL

Octinoxate 0.05mL / 1mL

Octisalate 0.05mL / 1mL

Octocrylene 0.025mL / 1mL

Oxybenzone 0.05mL / 1mL

Avobenzone 0.03mL / 1mL
DIRECTIONS:

Apply generously and evenly (equivalent to 3 tablespoons) to all areas before sun exposure. Spray on hands to apply to face. Do not spray on face. Reapply at frequent intervals, after swimming and towel drying. For external use only. Avoid contact with eyes and fabrics.
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.
CAUTION:

Over-exposure to the sun is a serious health threat. Reducing applied quantity will lower the level of protection significantly.
WARNING:

FLAMMABLE. DO NOT SPRAY ON NAKED FLAME OR ANY INCANDESCENT MATERIAL. KEEP AWAY FROM FLAMES, SPARKS OR SOURCES OF IGNITION.

KEEP OUT OF REACH OF CHILDREN.
INGREDIENTS:

Alcohol Denat., Homosalate, C12-15 Alkyl Benzoate, Ethylhexyl Salicylate, Ethylhexyl Methoxycinnamate, Benzophenone-3, Butyl Methoxydibenzoylmethane, Octocrylene, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe barbadensis, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Parfum, Alpha-isomethyl Ionone, Amyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Geraniol, Hexyl Cinnamal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool.
Contains Oxybenzone.

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

BANANA
BOAT®
QUICK DRY
SPORT
Body & Scalp
Rub-Free Sun Protection Spray
SPF 30 UVA
AvoTriplexTM
High Protection
Sun-Tested, Sun-ProvenTM
Sweat & Water
Resistant
Broad Spectrum
180 ml

INGREDIENTS AND APPEARANCE

BANANA BOAT SPORT BODY AND SCALP SPF 30
homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17630-2020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0878 mL in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 mL in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 mL in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.025 mL in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.05 mL in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
AMYL CINNAMAL (UNII: WC51CA3418)
BENZYL BENZOATE (UNII: N863NB338G)
GERANIOL (UNII: L837108USY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIMONENE, DL- (UNII: 9MC3I34447)
LINALOOL, DL- (UNII: D81QY6I88E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17630-2020-1	180 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/09/2009

Labeler - Accra-Pac, Inc. (024213616)

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

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Medic

BANANA BOAT SPORT BODY AND SCALP SPF 30 (HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE AND AVOBENZONE) LOTION [ACCRA-PAC, INC.]

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