BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL IVORY 15G- titanium dioxide, octinoxate, octisalate powder

BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL IVORY by

Drug Labeling and Warnings

BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL IVORY by is a Otc medication manufactured, distributed, or labeled by CJ OliveNetworks Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: TITANIUM DIOXIDE 12.24%, ETHYLHEXYL METHOXYCINNAMATE 6.70%, ETHYLHEXYL SALICYLATE 4.00%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Methyl Trimethicone, Cyclopentasiloxane, Glycerin,Lauryl PEG-10 Tris(Trimethylsiloxy)silylethylDimethicone, Dimethicone, Butylene Glycol, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Synthetic Fluorphlogopite, Butylene Glycol Dicaprylate/Dicaprate, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Iron Oxides (CI 77492),
Trisiloxane, Magnesium Sulfate, Phenoxyethanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Acrylates/Stearyl Acrylate/ Dimethicone Methacrylate Copolymer, Disteardimonium Hectorite, Stearic Acid, Alumina,
Triethoxycaprylylsilane, Iron Oxides (CI 77491), Aluminum Hydroxide,
Dimethicone Crosspolymer, Fragrance(Parfum), Caprylic/Capric Triglyceride,
Ethylhexylglycerin, Iron Oxides (CI 77499), Hydrogenated Lecithin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Ceramide NP, Aloe Ferox Leaf Extract, Nelumbo Nucifera Flower Water, Xylitylglucoside, Anhydroxylitol, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Xylitol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:
For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

DESCRIPTION

Uses:
Helps protect skin from UV rays.

Directions:
Squeeze a moderate amount on a puff and apply to face along with the skin texture evenly as a foundation and gently stroke to get it absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTANIC HEAL BOH DERMA WATER CERAMIDE AMPOULE CUSHION 01 NATURAL IVORY  15G
titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71596-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.83 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.00 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.60 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methyl Trimethicone (UNII: S73ZQI0GXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71596-055-02	2 in 1 PACKAGE	07/01/2019
1	NDC: 71596-055-01	15 g 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	07/01/2019

Labeler - CJ OliveNetworks Co., Ltd. (688271303)

Registrant - CJ OliveNetworks Co., Ltd. (688271303)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(71596-055)