BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18

Dosage form: cream
Ingredients: OCTINOXATE 7.5g in 100mL, TITANIUM DIOXIDE 8g in 100mL
Labeler: LIBINVEST
NDC Code: 52424-0001

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.

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 - 150 ml Label

Tinted
Cream Foundation

Sun Protectant
SPF 18

BIO BEAUTY BIO DEFENSE   TINTED FOUNDATION SPF 18
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52424-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE8 g  in 100 mL
Packaging
#Item CodePackage Description
1NDC:52424-0001-01 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
150 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/20/2010
BIO BEAUTY BIO DEFENSE   TINTED FOUNDATION SPF 18
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52424-0002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE8 g  in 100 mL
Packaging
#Item CodePackage Description
1NDC:52424-0002-0150 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/20/2010
Labeler - LIBINVEST (398739896)

Revised: 06/2010
 
LIBINVEST

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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