PURE BB CRE AM 21 LIGHT BEIGE by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co., Ltd.

PURE BB CRE AM 21 LIGHT BEIGE by

Drug Labeling and Warnings

PURE BB CRE AM 21 LIGHT BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURE BB CRE AM 21 LIGHT BEIGE- titanium dioxide, octinoxate, octisalate, zinc oxide 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 9.40%, ETHYLHEXYL METHOXYCINNAMATE6.00%, ETHYLHEXYL SALICYLATE 2.00%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

Inactive ingredients: WATER,CYCLOPENTASILOXANE,TITANIUM DIOXIDE,ETHYLHEXYL METHOXYCINNAMATE,GLYCERIN,CETYL ETHYLHEXANOATE,ISOSTEARYL ISOSTEARATE,METHYL TRIMETHICONE,PROPYLENE GLYCOL,CETYL PEG/PPG-10/1 DIMETHICONE,TALC,CAPRYLYL METHICONE,ETHYLHEXYL SALICYLATE,NIACINAMIDE,ZINC OXIDE,DIMETHICONE,IRON OXIDES(CI 77492),DISTEARDIMONIUM HECTORITE,PEG-10 DIMETHICONE,SILICA,MAGNESIUM SULFATE,PORTULACA OLERACEA EXTRACT,ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER,MICA,PHENOXYETHANOL,POLYGLYCERYL-4 ISOSTEARATE,METHICONE,BEESWAX,IRON OXIDES(CI 77491),ALUMINUM HYDROXIDE,AMINOPROPYL DIMETHICONE,ALUMINUM STEARATE,FRAGRANCE,POLYMETHYLSILSESQUIOXANE,ETHYLHEXYLGLYCERIN,TOCOPHERYL ACETATE,ALUMINA,POLYURETHANE-11,IRON OXIDES(CI 77499),ADENOSINE,HELICHRYSUM ITALICUM FLOWER WATER,HIBISCUS SABDARIFFA FLOWER EXTRACT,BUTYLENE GLYCOL,BUDDLEJA DAVIDII EXTRACT,THYMUS VULGARIS (THYME) EXTRACT,DIANTHUS CHINENSIS EXTRACT,NELUMBO NUCIFERA FLOWER EXTRACT,OCIMUM BASILICUM (BASIL) FLOWER/LEAF/STEM EXTRACT,ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT,EUCALYPTUS GLOBULUS LEAF EXTRACT

PURPOSE

Purpose: Sunscreen [UV Protection ] This premium BB cream keeps the skin moist by forming a protective film over the skin. Its excellent coverage function keep your makeup for long hours.

Cautions

Cautions: 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.

How to use

How to use: At the last step of skin care, apply an appropriate amount to the entire face in a gentle tapping motion to achieve natural makeup.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PURE BB CRE AM 21 LIGHT BEIGE 
titanium dioxide, octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-455
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide1.14 g  in 15 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.90 g  in 15 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.30 g  in 15 mL
Zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.28 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-455-021 in 1 CARTON02/01/201511/01/2019
1NDC: 51346-455-0115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201511/01/2019
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(51346-455)

Revised: 2/2020
Document Id: cd91ed4c-4e68-425c-9095-b1df995f259c
Set id: e14ae971-8946-403f-9519-fe2ee1be3930
Version: 2
Effective Time: 20200225