INCELLDERM COCKTAIL AQUA SUN- octinoxate, octisalate, homosalate, titanium dioxide gel

INCELLDERM Cocktail Aqua Sun by

Drug Labeling and Warnings

INCELLDERM Cocktail Aqua Sun by is a Otc medication manufactured, distributed, or labeled by Riman Co., Ltd., HANSOLBIOTECH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%, Titanium Dioxide 1.49%

INACTIVE INGREDIENT

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Butylene Glycol, Ethyl Hexanediol, 1,2-Hexanediol, Niacinamide, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Aluminum Hydroxide, Stearic Acid, Caprylyl Methicone, Glycerin, Ethylhexy Triazone, Isononyl Isononanoate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Sorbitan Oleate, Water, Water, Sodium Hyaluronate, 1,2-Hexanediol, 1,2-Hexanediol, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allantoin, Tocopheryl Acetate, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens Flower Oil, Amyris Balsamifera Bark Oil, Citrus Grandis (Grapefruit) Peel Oil, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Juniperus Mexicana Oil, Boswellia Carterii Oil, Sorbitan Isostearate, Ethylhexylglycerin, Adenosine, Xanthan Gum, Glycerin, Water, Pancratium Maritimum Extract, Water, Butylene Glycol, Sophora Japonica Fruit Extract, Ethyl Hexanediol, 1,2-Hexanediol, Water, Butylene Glycol, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Methylglucose Distearate

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

1. Consult a physician if red spots, swollenness, itchiness, or any other adnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.
2. Do not use on wound, etc.
3. Precautions for handling and storage
a) Keep out of the reach of children
b) Avoid direct sunlight

DESCRIPTION

Uses:
Protects skin from UV rays (SPF50 + / PA +++)

Directions:
After gently shaking it up and down, apply to the skin or mix with the cocktail BB and apply to the whole face. Apply this product once every 2 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INCELLDERM COCKTAIL AQUA SUN 
octinoxate, octisalate, homosalate, titanium dioxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72650-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.50 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.74 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72650-060-02	1 in 1 CARTON	03/01/2019
1	NDC: 72650-060-01	50 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	03/01/2019

Labeler - Riman Co., Ltd. (694893735)

Registrant - Riman Co., Ltd. (694893735)

Establishment
Name	Address	ID/FEI	Business Operations
HANSOLBIOTECH		694455165	manufacture(72650-060)