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

CALIFORNIA ALOE DAILY SUN BLOCK by

Drug Labeling and Warnings

CALIFORNIA ALOE DAILY 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 DAILY SUN BLOCK- zinc oxide, homosalate, ethylhexyl salicylate, 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 INGREDIENTS

ZINC OXIDE 12.7%
HOMOSALATE 7.5%
ETHYLHEXYL SALICYLATE 4.5%
TITANIUM DIOXIDE 2.2%

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, COCO-CAPRYLATE/CAPRATE, DIPROPYLENE GLYCOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, GLYCERIN, NIACINAMIDE, BUTYLOCTYL SALICYLATE, METHYL METHACRYLATE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, DIMETHICONE, 1,2-HEXANEDIOL, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, ALUMINUM HYDROXIDE, SORBITAN CAPRYLATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, FRAGRANCE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DICAPRYLYL CARBONATE, GLYCERYL CAPRYLATE, MICA, IRON OXIDES(CI 77492), ETHYLHEXYLGLYCERIN, ADENOSINE, IRON OXIDES(CI 77491), SODIUM CITRATE, IRON OXIDES(CI 77499), SEA WATER, BUTYLENE GLYCOL, TOCOPHEROL, ALOE BARBADENSIS LEAF EXTRACT, PHENOXYETHANOL, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, MORINDA CITRIFOLIA EXTRACT, PENTYLENE GLYCOL, CAPRYLYL GLYCOL

PURPOSE

Sunscreen

WARNINGS

For external use only. Avoid contact with eyes. In the event of contact with eyes, rinse thoroughly with water. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace cap after use.

DESCRIPTION

Uses
Protects skin from direct sunlight and UV rays.

Directions
Apply adequate amount of the product and thoroughly apply on the areas exposed to the UV rays. Apply the sunscreen product before exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming or toweling.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIFORNIA ALOE DAILY SUN BLOCK 
zinc oxide, homosalate, ethylhexyl salicylate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-533
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.23 g  in 57 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.27 g  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.56 g  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.25 g  in 57 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-533-01	57 mL in 1 CARTON; Type 0: Not a Combination Product	08/01/2020	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2020	12/01/2021

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-533)

Revised: 10/2022

Document Id: 91737aca-2fd3-4e99-bf85-72bb12fcbe7c

34390-5

Set id: 480af4bd-96f2-4280-bd15-0a4d50d0de76

Version: 3

Effective Time: 20221021