CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE- octinoxate, homosalate, octisalate gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
Coshub Co., Ltd.
INN (International Name):
Octinoxate
Composition:
Octinoxate 3.50 g in 50 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
71702-060-01, 71702-060-02

CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE- octinoxate, homosalate, octisalate gel

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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate

4.50%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol,

Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract,

Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance,

Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine,

Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine

Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract,

Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra

Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3

Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891),

C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic

Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic

Acid, Glyceryl Caprylate, Squalane

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

CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE

octinoxate, homosalate, octisalate gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7170 2-0 6 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O ctino xa te (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

O c tino xa te

3.50 g in 50 mL

Ho mo sa la te (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

Ho mo sa la te

3.0 0 g in 50 mL

Coshub Co., Ltd.

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

2.25 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:7170 2-0 6 0 -

1 in 1 CARTON

0 8 /0 1/20 17

1

NDC:7170 2-0 6 0 -0 1

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 8 /0 1/20 17

Labeler -

Coshub Co., Ltd. (689846820)

Registrant -

Coshub Co., Ltd. (689846820)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

COSON Co ., Ltd._Osan Plant

6 8 9 8 47210

ma nufa c ture (7170 2-0 6 0 )

Revised: 9/2017

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