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SUNSCREEN SPF 28

Dosage form: cream
Ingredients: OCTINOXATE 7.5g in 100g, ZINC OXIDE 6g in 100g
Labeler: COSMOCEUTICAL RESEARCH CENTER INC
NDC Code: 66538-101

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.

SUNSCREEN SPF 28/30

ACTIVE INGREDIENTS:
OCTINOXATE 7.5%
ZINC OXIDE 6%

PURPOSE:
SUNSCREEN

INDICATION:
HELPS PREVENT SUNBURN

WARNING: FOR EXTERNAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS: APPLY A THIN LAYER TO ALL EXPOSED AREAS. REAPPLY AFTER PROLONGED SWIMMING, EXTREME PERSPIRATION OR TOWEL DRYING.

INACTIVE INGREDIENTS: PURIFIED WATER, POLYGLYCERYL-4 ISOSTEARATE, CETYL DIMETHICONE COPOLYOL, HEXYL LAURATE, OCTYL PALMITATE, CYCLOMETHICONE, PHENYL TRIMETHICONE, CETYL DIMETHICONE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, SODIUM CHLORIDE, PROPYLENE GLYCOL, SODIUM PCA, ALOE BARBADENSIS EXTRACT, ALLANTOIN, TETRASODIUM EDTA, TOCOPHERYL ACETATE.

CRC
SUNSCREEN
UVA/UVB
SPF 28/30
1.75 OZ. (50 G)


WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

SUNSCREEN  SPF 28
octinoxate zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66538-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYGLYCERYL-4 ISOSTEARATE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
HEXYL LAURATE 
ETHYLHEXYL PALMITATE 
CYCLOMETHICONE 
PHENYL TRIMETHICONE 
DIMETHICONE 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
ETHYLPARABEN 
BUTYLPARABEN 
ALLANTOIN 
SODIUM CHLORIDE 
PROPYLENE GLYCOL 
SODIUM PYRROLIDONE CARBOXYLATE 
ALOE 
EDETATE SODIUM 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:66538-101-1250 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/28/2011
Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)
Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)

Revised: 02/2012
Document Id: 5f1ee376-412a-4978-ab8e-0480170b280a
Set id: 1a581d40-0326-43f6-932a-d0e2c980f4e2
Version: 2
Effective Time: 20120203
 
COSMOCEUTICAL RESEARCH CENTER INC

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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