CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co.,LTD. Gwanjeong Factory

CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK- titanium dioxide 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

TITANIUM DIOXIDE 2.3%

INACTIVE INGREDIENTS

WATER, DIBUTYL ADIPATE, PROPANEDIOL, ETHYLHEXYL TRIAZONE, TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID, ALCOHOL, GLYCERIN, COCO-CAPRYLATE/CAPRATE, NIACINAMIDE, TROMETHAMINE, POLYGLYCERYL-3 DISTEARATE, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CAPRYLYL METHICONE, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, POLYSILICONE-15, CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, GLYCERYL STEARATE, POLYMETHYLSILSESQUIOXANE, POTASSIUM CETYL PHOSPHATE, METHYLPROPANEDIOL, POLYHYDROXYSTEARIC ACID, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALUMINA, TRIETHOXYCAPRYLYLSILANE, GLYCERYL STEARATE CITRATE, ETHYLHEXYLGLYCERIN, ARTEMISIA VULGARIS OIL, ADENOSINE, SEA WATER, POLYETHER-1, BUTYLENE GLYCOL, PVM/MA COPOLYMER, SODIUM POLYACRYLATE, PHENOXYETHANOL, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, MORINDA CITRIFOLIA EXTRACT, BIOSACCHARIDE GUM-1, TOCOPHEROL

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
Helps prevent sunburn while moisturizing and providing tone-up effect

Directions
Apply an appropriate amount to the skin before exposure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-540
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-540-021 in 1 CARTON03/01/202206/01/2022
1NDC: 51346-540-0157 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/202206/01/2022
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(51346-540)

Revised: 6/2022