Your browser does not support JavaScript! BANANA BOAT KIDS PROTECT AND PLAY SPF 85 (AVOBENZONE AND HOMOSALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]
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BANANA BOAT KIDS PROTECT AND PLAY SPF 85 (avobenzone and homosalate and octocrylene and oxybenzone) spray
[Accra-Pac, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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)

PRINCIPAL DISPLAY PANEL
Banana Boat Kids Protect and Play SPF 85

BANANA BOAT KIDS PROTECT AND PLAY SPF 85 
avobenzone and homosalate and octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:17630-2016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 mL  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE0.15 mL  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.10 mL  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE0.06 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
DICAPRYLYL CARBONATE 
CAPRYLYL GLYCOL 
ALOE VERA LEAF 
VITAMIN A PALMITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17630-2016-1177 mL in 1 CAN
2NDC:17630-2016-2236 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/01/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIBusiness Operations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 3/2010
 
Accra-Pac, Inc.

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