PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co.,Ltd. Bucheon Factory

PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co.,Ltd. Bucheon Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE- zinc oxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate powder 
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 INGREDIENTS

ZINC OXIDE 4.80%
ETHYLHEXYL METHOXYCINNAMATE 3.75%
ETHYLHEXYL SALICYLATE 2.50%

INACTIVE INGREDIENTS

TALC, BORON NITRIDE, POLYMETHYL METHACRYLATE, SILICA, SYNTHETIC FLUORPHLOGOPITE, NYLON-12, DIMETHICONE, MAGNESIUM MYRISTATE, PHENYL TRIMETHICONE, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES(CI 77492), 1,2-HEXANEDIOL, METHICONE, GLYCERYL CAPRYLATE, MICA, IRON OXIDES(CI 77491), FRAGRANCE, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES(CI 77499), WATER, ALOE BARBADENSIS LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, CAMELLIA SINENSIS LEAF EXTRACT, BUTYLENE GLYCOL, ROSA HYBRID FLOWER EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, PHENOXYETHANOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, CITRIC ACID, SODIUM BENZOATE, ETHYL HEXANEDIOL

PURPOSE

Sunscreen

WARNINGS

For external use only.
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Keep out of reach of children.

DESCRIPTION

Uses
Light textured powder pact provides long lasting coverage with UV protection.

Directions
Apply an appropriate amount to the skin evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE 
zinc oxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-536
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.80 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-536-021 in 1 CARTON12/20/201609/01/2022
1NDC: 51346-536-0110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/20/201609/01/2022
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,Ltd. Bucheon Factory689847167manufacture(51346-536)

Revised: 10/2022