CLEMATIS MORNING DEW BB 23 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide cream
Coshub 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.

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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 8.12%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Iron Oxides(CI77492), Disteardimonium Hectorite, Ozokerite, Trimethylsiloxyphenyl Dimethicone, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Iron Oxides(CI77491), Phenoxyethanol, Triethoxycaprylylsilane, Beeswax, Iron Oxides(CI77499), Aluminum Hydroxide, Ethylhexylglycerin, Fragrance, Adenosine, Silica dimethyl silylate, Disodium EDTA

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

DESCRIPTION

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLEMATIS MORNING DEW BB 23 NATURAL BEIGE
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71702-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.06 g in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.00 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71702-100-02	1 in 1 CARTON	08/01/2017
1	NDC:71702-100-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2017

Labeler - Coshub Co., Ltd. (689846820)

Registrant - Coshub Co., Ltd. (689846820)

Name	Address	ID/FEI	Business Operations
Establishment
COSON Co., Ltd._Osan Plant		689847210	manufacture(71702-100)