RA SENCE LOE CURE AIR LIGHT UV SHIELD SUN- octinoxate, octocrylene, octisalate stick

Ra Sence Loe Cure Air light UV shield Sun by

Drug Labeling and Warnings

Ra Sence Loe Cure Air light UV shield Sun by is a Otc medication manufactured, distributed, or labeled by Kimjeongmoon Aloe Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%

INACTIVE INGREDIENT

Inactive ingredients:

Butylene Glycol Dicaprylate/Dicaprate, Octyldodecanol, Butyloctyl Salicylate, Polyamide-8, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Ethylhexyl Methoxycrylene, BHT, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Caprylyl Glycol, Coccinia Indica Fruit Extract, Ethylhexylglycerin, Solanum Melongena (Eggplant)Fruit Extract,Amber owder, Curcuma longa (Tumeric)Root Extract, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Moringa Pterygosperma Seed Oil, Camellia Oleifera Seed Oil, Argania Spinosa Kernel Oil, Prunus Amygdalus Dulcis (Sweet Almond) oil, Limnanthes Alba (Meadowfoam) Seed Oil, Eucalyptus Globulus Leaf Oil, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Husk Oil, Adansonia Digitata Seed Oil, Rosmariunus Officinalis (Rosemary) Leaf Oil, Ale Barbadensis Leaf Juice, Butylene Glycol, Camellia Japonica Flower Extract, Dipropylene Glycol, Xylitylglucoside, Sodium Palmitoyl Proline, Anhydroxylitol, Water, Nelumbo Nucifera Flower Extract, Uncaria Gambir extract, Sanguisorba Officinalis Root extract, Cinnamomum Zeylanicum Bark Extract, Pelargonium Graveolens Extract, xylitol, Nyphaea Alba Flower extract, 1,2-Hexanediol, Glucose

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

DESCRIPTION

Uses:

A clear aloe stick sun screen, easy to apply to curved area, works over and under make up for sun protection.

Directions:

-Turn the dial at the bottom of the container and push up roughly.

-Apply liberally to face and all over the body frequently after sun exposure.

-Product can be applied over and under the makeup.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RA SENCE LOE CURE AIR LIGHT UV SHIELD SUN 
octinoxate, octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50410-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.4 g  in 20 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.0 g  in 20 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.9 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
Octyldodecanol (UNII: 461N1O614Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50410-120-02	1 in 1 CARTON	11/01/2018
1	NDC: 50410-120-01	20 mL in 1 CONTAINER; 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	11/01/2018

Labeler - Kimjeongmoon Aloe Co., Ltd. (689253722)

Registrant - Kimjeongmoon Aloe Co., Ltd. (689253722)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(50410-120)