Drug Facts

Active Ingredients

HOMOSALATE 9.0%
OCTOCRYLENE 9.0%
ETHYLHEXYL SALICYLATE 4.5%
BUTYL METHOXYDIBENZOYLMETHANE 2.9%

Purpose

Sunscreen

Uses

Protects skin from direct sunlight and UV rays.

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.

Keep out of reach of children.

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.

Inactive Ingredients

POLYETHYLENE, PROPYLHEPTYL CAPRYLATE, DIMETHICONE, SILICA, ISOPROPYL PALMITATE, METHYL METHACRYLATE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, DICAPRYLYL CARBONATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ACRYLATES COPOLYMER, OZOKERITE, FRAGRANCE, LAURYL PEG-8 DIMETHICONE, DEHYDROACETIC ACID, POLYGLYCERYL-2 TRIISOSTEARATE, TOCOPHEROL, YELLOW 5 LAKE(CI 19140), WATER, SEA WATER, BUTYLENE GLYCOL, PHENOXYETHANOL, ALOE BARBADENSIS LEAF EXTRACT, HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, MORINDA CITRIFOLIA EXTRACT, PENTYLENE GLYCOL, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN

PRINCIPAL DISPLAY PANEL

Image of carton

CALIFORNIA ALOE FRESH POW DERY SUN
homosalate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-532
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.89 g in 21 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.89 g in 21 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.94 g in 21 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.6 g in 21 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-532-01	21 g in 1 CARTON; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/01/2020

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,Ltd. Bucheon Factory		963271763	manufacture(51346-532)

California Aloe Fresh Powdery Sun Stick SPF 50