Banana Boat Kids Protect And Play Spf 85 (Avobenzone And Homosalate And Octocrylene And Oxybenzone) Spray [Accra-Pac, Inc.] -

BANANA BOAT KIDS PROTECT AND PLAY SPF 85 (AVOBENZONE AND HOMOSALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]
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NDC	17630-2016-1, 17630-2016-2
Set ID	5a1bf0be-2a9f-409a-b91e-31ee02913430
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

Drug Facts
Active Ingredients

Avobenzone 0.03mL / 1mL

Homosalate 0.15mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.06mL / 1mL
Purpose

Sunscreen
Use

helps prevent sunburn
Warnings
- For external use only
- Do not spray directly into face
- Flammable: do not use near heat, flame, or while smoking
When using this product
- avoid spraying in eyes. If contact occurs, rinse thoroughly with water.
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Stop use and ask a doctor if

irritation or rash develops

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
- spray on hands to apply to face
- use in well-ventilated area
- reapply at frequent intervals and after swimming or towel drying
- ask a doctor before use on children under six months of age
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.
Inactive Ingredients

SD Alcohol 40-B, Cyclopentasiloxane, Cyclohexasiloxane, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/Tricaprate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Fragrance.
Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484
PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
KiDS
Protect & PlayTM
Continuous Spray Sunscreen
SPF/UVB 85

PEDIATRICIAN TESTED
AvoTriplexTM
High UVA
Long-Lasting Protection
Sun-Tested, Sun-ProvenTM
Invisible, Rub-Free
Hypoallergenic
Very Water/Sweat Resistant
6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT KIDS PROTECT AND PLAY SPF 85
avobenzone and homosalate and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17630-2016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.15 mL in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.10 mL in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

#	Item Code	Package Description
Packaging
1	NDC:17630-2016-1	177 mL in 1 CAN
2	NDC:17630-2016-2	236 mL in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2009

Labeler - Accra-Pac, Inc. (024213616)

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

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Medic

BANANA BOAT KIDS PROTECT AND PLAY SPF 85 (AVOBENZONE AND HOMOSALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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