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 carton

CALIFORNIA ALOE MOISTURIZING TONE UP SUN BLOCK
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-540
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
PROPANEDIOL (UNII: 5965N8W85T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-540-02	1 in 1 CARTON	03/01/2022	06/01/2022
1	NDC:51346-540-01	57 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2022	06/01/2022

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-540)

Revised: 6/2022

Document Id: aa1c7f17-b878-4bdf-80ea-6d730129b712

Set id: 29203ca0-42df-4667-9a64-e69131c385d3

Version: 2

Effective Time: 20220628

NATURE REPUBLIC CO., LTD.