PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE - titanium dioxide, octinoxate, octisalate cream 
NATURE REPUBLIC CO., LTD.

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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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 7.16%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Phenoxyethanol, Triceteareth-4 Phosphate, Glycol Stearate, PEG-10 Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Cetyl Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Hydroxide, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Tromethamine, Isohexadecane, Ethylhexylglycerin, Fragrance(Parfum), Iron Oxides (CI 77499), Adenosine, Polysorbate 80, Disodium EDTA, Sorbitan Oleate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Water, Rosa Centifolia Flower Water, Mica (CI 77019), Camellia Sinensis Leaf Extract, Alcohol, Saccharomyces Ferment

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

DESCRIPTION

Uses: The BB cream with an air-like texture perfectly adheres to the skin

Directions: Apply an appropriate amount to the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE  
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-483
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.14 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.10 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.90 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-483-021 in 1 CARTON06/01/201712/30/2019
1NDC:51346-483-0130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201712/30/2019
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(51346-483)

Revised: 6/2021
 
NATURE REPUBLIC CO., LTD.