Ra Sence Loe Cure Air Light UV Shield Sun: Package Insert and Label Information

RA SENCE LOE CURE AIR LIGHT UV SHIELD SUN- octinoxate, octocrylene and octisalate stick
Kimjeongmoon Aloe 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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (OCTINOXATE) Octinoxate 1.4 g in 20 mL
Octocrylene (OCTOCRYLENE) Octocrylene 1.0 g in 20 mL
Octisalate (OCTISALATE) Octisalate 0.9 g in 20 mL
Inactive Ingredients
Ingredient Name Strength
Butylene Glycol
Octyldodecanol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50410-120-02 1 CONTAINER in 1 CARTON contains a CONTAINER (50410-120-01)
1 NDC:50410-120-01 20 mL in 1 CONTAINER This package is contained within the CARTON (50410-120-02)
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 Operations
Cosmecca Korea Co., Ltd. 688830827 manufacture (50410-120)

Revised: 11/2018 Kimjeongmoon Aloe Co., Ltd.

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