BECCA MINERAL SPF PRIMER - zinc oxide cream 
Becca, Inc.

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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Mineral SPF30 Primer

Active Ingredients                  Purpose

Zinc Oxide 17%                     Sunscreen

provides very high protection against sunburn

Keep out of reach of children

For external use only.

Avoid contact with eyes.

-Discontinue if signs of irritation or rash appear

-Keep out of reach of children

-Ask a doctor before use on children under six months

-Contains hydroxybenzoates and phenoxyethanol

-Apply generously 15 to 20 minutes before sun exposure and again after swimming or toweling

Inactive Ingredients: Aqua (water-purified), Cyclomethicone, Caprylic/Capric Triglyceride, Glyceryl Distearate, Ceteareth-20 (Cetomacrogol 1000), PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Methylparaben (Methyl Hydroxybenzoate), Tocopheryl acetate (D-Alpha-Tocopheryl Acetate), Parfum (Fragrance), Carbomer (Carbomer 940), Camellia Sinensis Extract (Camellia Sinensis Leaf Extract, Oenothera Biennis Oil (Evening Primrose Oil), Sodium Hyaluronate, Propylparaben (Propyl Hydroxybenzoate), Ubiquinone 10 (Ubidecarenone).



image of secondary label

Becca

Mineral SPF Primer

SPF 30

50 ml. / 1.7 fl.oz



image of primary label

BECCA  MINERAL SPF PRIMER
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51147-5010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
UBIDECARENONE (UNII: EJ27X76M46)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51147-5010-21 in 1 BOX
1NDC:51147-5010-150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/12/2011
Labeler - Becca, Inc. (002000729)
Registrant - Becca, Inc. (002000729)
Establishment
NameAddressID/FEIBusiness Operations
Jalco Cosmetic Pty. Ltd.755470184manufacture

Revised: 4/2011
Document Id: 14f39df9-e360-41ef-a046-da5c81c6cea1
Set id: f4923279-ebae-4565-88d7-5423945aac0f
Version: 3
Effective Time: 20110414
 
Becca, Inc.