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Name:Beccamineral Spf Primer
Manufacturer:Becca, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Mineral SPF30 Primer

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51147-5010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 17 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE  
MEDIUM-CHAIN TRIGLYCERIDES  
GLYCERYL DISTEARATE  
POLYOXYL 20 CETOSTEARYL ETHER  
PEG-30 DIPOLYHYDROXYSTEARATE  
PHENOXYETHANOL  
METHYLPARABEN  
.ALPHA.-TOCOPHEROL ACETATE, D-  
CARBOMER HOMOPOLYMER TYPE C  
GREEN TEA LEAF  
EVENING PRIMROSE OIL  
HYALURONATE SODIUM  
PROPYLPARABEN  
UBIDECARENONE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51147-5010-2 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (51147-5010-1)
1 NDC:51147-5010-1 50 mL in 1 BOTTLE This package is contained within the BOX (51147-5010-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/12/2011

Labeler - Becca, Inc. (002000729)
Registrant - Becca, Inc. (002000729)
Establishment
Name Address ID/FEI Operations
Jalco Cosmetic Pty. Ltd. 755470184 manufacture

Revised: 04/2011 Becca, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine

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