CALIFORNIA ALOE MILD SUN BLOCK- octinoxate, homosalate, octisalate, titanium dioxide cream

CALIFORNIA ALOE MILD by

Drug Labeling and Warnings

CALIFORNIA ALOE MILD 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]

ACTIVE INGREDIENT

Active ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, HOMOSALATE 5.0%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 1.18%

INACTIVE INGREDIENT

Inactive ingredients: WATER, DICAPRYLYL CARBONATE, DIPROPYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, CYCLOPENTASILOXANE, C14-22 ALCOHOLS, PEG-100 STEARATE, GLYCERYL STEARATE, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, CETEARYL ALCOHOL, SILICA, C12-20 ALKYL GLUCOSIDE, PHENOXYETHANOL, FRAGRANCE, OLETH-10, PROPANEDIOL, ALUMINUM STEARATE, POLYACRYLATE-13, OCTYLDODECANOL, ISODECETH-6, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ALLANTOIN,XANTHAN GUM, SEA WATER, ALUMINA, POLYISOBUTENE, POLYURETHANE-11, ECHIUM PLANTAGINEUM SEED OIL, SIMETHICONE, POLYSORBATE 20, PORTULACA OLERACEA EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, ETHYLHEXYLGLYCERIN, MORINDA CITRIFOLIA EXTRACT, PENTYLENE GLYCOL, CAPRYLYL GLYCOL, TOCOPHEROL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children Replace the cap after use

DESCRIPTION

Uses: A mild and hypoallergenic sun block for sensitive baby and adult skin.

Directions: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALIFORNIA ALOE MILD  SUN BLOCK
octinoxate, homosalate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-487
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.87 g  in 57 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.85 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	0.67 g  in 57 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-487-02	1 in 1 CARTON	06/01/2017
1	NDC: 51346-487-01	57 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2017

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-487)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(51346-487)