Sun Block

Dosage form: cream
Ingredients: OCTINOXATE 8mL in 100mL, OXYBENZONE 7.5mL in 100mL, TITANIUM DIOXIDE 8mL in 100mL, HOMOSALATE 6mL in 100mL
Labeler: Yuyao Jessie Promotional Products Co., Ltd.
NDC Code: 51414-200

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.

Sunblock DRUG FACT

Active Ingredient OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

UseProtection from the sun’s damaging effects

WarningsFor external use only                                                         
Not recommended for children under 6 months of age

DirectionApply liberally and evenly before sun exposure.   

Inactive IngredientWater,CetearylAlcohol,Glycerinmonostearate,                               
Gctt,Propylparaben,Methylparaben,                                    
glycerol,EDTA-2NA,Vinylchloride-methylacrylate,                   
copolymer,Methylisothiazolinone 

SUN BLOCK 
octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE8 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE7.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE8 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE6 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:51414-200-0115 mL in 1 BOTTLE
2NDC:51414-200-0220 mL in 1 BOTTLE
3NDC:51414-200-0330 mL in 1 BOTTLE
4NDC:51414-200-0440 mL in 1 BOTTLE
5NDC:51414-200-0550 mL in 1 BOTTLE
6NDC:51414-200-0660 mL in 1 BOTTLE
7NDC:51414-200-0770 mL in 1 BOTTLE
8NDC:51414-200-0880 mL in 1 BOTTLE
9NDC:51414-200-0990 mL in 1 BOTTLE
10NDC:51414-200-10100 mL in 1 BOTTLE
11NDC:51414-200-11200 mL in 1 BOTTLE
12NDC:51414-200-12250 mL in 1 BOTTLE
13NDC:51414-200-13300 mL in 1 BOTTLE
14NDC:51414-200-14400 mL in 1 BOTTLE
15NDC:51414-200-15500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/30/2010
Labeler - Yuyao Jessie Promotional Products Co., Ltd. (529892305)
Establishment
NameAddressID/FEIOperations
Yuyao Jessie Promotional Products Co., Ltd.529892305manufacture

Revised: 07/2010
 
Yuyao Jessie Promotional Products Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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