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Name:Banana Boat Sport Body And Scalp Spf 30
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Sport Body and Scalp SPF 30

BANANA BOAT SPORT BODY AND SCALP SPF 30 - homosalate, octinoxate, octisalate, octocrylene, oxybenzone and avobenzone lotion 
Accra-Pac, Inc.

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.

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Banana Boat Sport Body and Scalp SPF 30

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
 

PRINCIPAL DISPLAY PANEL
Banana Boat Sport Body and Scalp SPF 30


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.0878 mL  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.05 mL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.05 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.025 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.05 mL  in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
C12-15 ALKYL BENZOATE  
CAPRYLYL GLYCOL  
VITAMIN A PALMITATE  
AMYL CINNAMAL  
BENZYL BENZOATE  
GERANIOL  
ALOE VERA LEAF  
LIMONENE, DL-  
LINALOOL, DL-  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2020-1 180 mL in 1 BOTTLE None

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

Labeler - Accra-Pac, Inc. (024213616)
Establishment
Name Address ID/FEI Operations
Accra-Pac, Inc. 024213616 MANUFACTURE

Revised: 03/2010 Accra-Pac, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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