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Name:Bio Beauty Bio Defense Tinted Foundation Spf 18
Manufacturer:Libinvest
Category:Over-the-counter (OTC) Marketed Drugs


Tinted Cream Foundation

BIO BEAUTY BIO DEFENSE  TINTED FOUNDATION SPF 18 - octinoxate and titanium dioxide cream 
LIBINVEST

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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Tinted
Cream Foundation

ACTIVE INGREDIENTS
OCTINOXATE 7.5% Sunscreen
TITANIUM DIOXIDE 8.0% Sunscreen

USES

Use as a foundation, helps prevent sunburn, higher SPF gives more sunburn protection.

WARNINGS

For external use only. Not to be swallowed. Avoid contact with the eyes.

Stop use and ask doctor if rash develops and lasts.

Keep out of reach of children.

DIRECTIONS

Use in place of your normal foundation.

INACTIVE INGREDIENTS

WATER, GLYCERYL STEARATE/ISOPROPYLENE GLYCOL STEARATE/GLYCERYLISOSTEARATE/OLETH-25/CETETH-25, ISODECETH-6, OLETH-10, ALUMINUM STEARATE, ALUMINA, SIMETHICONE, PROPYLENE GLYCOL DIPELARGONATE, METHYL METHACRYLATE CROSSPOLYMER, OCTYLDODECYL MYRISTATE, PALMITOYL PROLINE and MAGNESIUM PALMITOYL GLUTAMATE and SODIUM PALMITOYL SARCOSINATE, IRON OXIDES, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, BENZOPHENONE-3, GLYCERYL STEARATE and BEHENYL LAURYL MYRISTYL CETYL ALCOHOL and PALMITIC STEARIC ACID and LECITHIN, MAGNESIUM ALUMINUM SILICATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, FRAGRANCE, TOCOPHERYL ACETATE, GUM XANTHAN, ALLANTION, METHYLISOTHIAZOLINONE.

Distributed by Primo Derma, Inc. Santa Ana, CA 92705
Tel: ++001-714-560 0111

PRINCIPAL DISPLAY PANEL - 50 ml Label

Tinted
Cream Foundation

Sun Protectant
SPF 18

PRINCIPAL DISPLAY PANEL - 50 ml Label

PRINCIPAL DISPLAY PANEL - 150 ml Label

Tinted
Cream Foundation

Sun Protectant
SPF 18

PRINCIPAL DISPLAY PANEL - 150 ml Label

BIO BEAUTY BIO DEFENSE   TINTED FOUNDATION SPF 18
octinoxate and titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52424-0001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 8 g  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52424-0001-0 1 BOTTLE, PLASTIC ( BOTTLE) in 1 BOX contains a BOTTLE, PLASTIC
1 50 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (52424-0001-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/20/2010

BIO BEAUTY BIO DEFENSE   TINTED FOUNDATION SPF 18
octinoxate and titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52424-0002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 8 g  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52424-0002-0 150 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/20/2010

Labeler - LIBINVEST (398739896)

Revised: 06/2010 LIBINVEST



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


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