NDC | 50410-120-01, 50410-120-02 |
Set ID | bd378a67-e7af-43f7-9796-416ee0b05fa0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Kimjeongmoon Aloe Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%
Close - 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
Close - PURPOSE
- 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
Close - 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.
Close - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
RA SENCE LOE CURE AIR LIGHT UV SHIELD SUN
octinoxate, octocrylene, octisalate stickProduct 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)