- octinoxate, octisalate, oxybenzone, titanium dioxide spray 
Shanghai Kejing Cleaning Products Co., Ltd.

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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Active Ingredients

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

Titanium Dioxide 2.5%

Purpose

Sunscreen

Uses: Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun

increase your risk of skin cancer and early skin aging.

this product had been shown only to prevent sunburn,

not skin cancer or skin aging.

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product swallowed, get

medical help or contact a Poison Control Center right away.

Directions

Apply generously & evenly before sun exposure. Reapply as

needed or after towel drying, swimming or sweating.

Ask doctor before using on children under 6 months.

Inactive ingredients

Water, Cetearyl Alcohol, Xanthan Gum,

C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol,

Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl

Butylcarbamate, DMDM Hydantoin, Fragrance

Other information

Protect this product from excessive heat and direct sun

Questions or Comment? Call toll free 1-877-254-2281

Insect repellent active ingredients: soybean oil  3%

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octinoxate, octisalate, oxybenzone, titanium dioxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A) SOYBEAN OIL3.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTYL PROPIONATE (UNII: P59053E7NJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31190-230-0130 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
2NDC:31190-230-0260 g in 1 PACKAGE; Type 0: Not a Combination Product06/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/25/2016
Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(31190-230)

Revised: 6/2016
Document Id: 868b99f5-15d0-4e5b-aa34-944c825b3286
Set id: acc70903-6f3a-45db-a1d5-f586341d2214
Version: 1
Effective Time: 20160625
 
Shanghai Kejing Cleaning Products Co., Ltd.