KOPHER CALMING OCEAN SUN- ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide cream

Kopher Calming Ocean Sun by

Drug Labeling and Warnings

Kopher Calming Ocean Sun by is a Otc medication manufactured, distributed, or labeled by Best Innovation, Cit Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Ethylhexyl Methoxycinnamate 7.50%
Zinc Oxide 4.00%
Ethylhexyl Salicylate 3.00%
Titanium Dioxide (CI 77891) 1.60%

INACTIVE INGREDIENTS

Glacier Water, Cyclopentasiloxane, Butylene Glycol, Dicaprylyl Carbonate, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Centella Asiatica Extract, Sodium Chloride, Asiaticoside, Madecassic Acid, Asiatic Acid, Spirulina Platensis Extract, Scutellaria Baicalensis Root Extract, Cinnamomum Zeylanicum Bark Extract, Camellia Japonica Seed Oil, Ceresin, Allantoin, Disteardimonium Hectorite, Sorbitan Sesquioleate, Silica, Sorbitan Olivate, Trihydroxystearin, Trimethylsiloxysilicate, Dipropylene Glycol, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Phenyl Trimethicone, Triethoxycaprylylsilane, Dimethicone Crosspolymer, CI 77492, Dimethiconol, Adenosine, Dimethicone, CI 77491, Tocopherol, Menthyl Lactate, Butyl Methoxydibenzoylmethane, Butyl Avocadate, Tocopheryl Acetate, Horse Fat, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Capryloyl Glycine, Hexylene Glycol, Sarcosine, Chlorphenesin, Water, Talc, Fragrance(Parfum)

PURPOSE

Sunscreen

WARNINGS

■ FOR EXTERNAL USE ONLY
■ Do not use on damaged or broken skin.
■ When using this product, keep out of eyes. Rinse with water to remove.
■ Stop use and ask a doctor if rash occurs.
■ Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control

Uses

■ Helps prevent sunburn
■ Higher SPF gives more sunburn protection
■ Retains SPF after 80 minutes of activity in the water or sweating

Directions

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
■ Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

■ www.bestinnovation.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOPHER CALMING OCEAN SUN 
ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83069-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.50 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.0 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.60 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83069-010-02	1 in 1 CARTON	10/01/2022
1	NDC: 83069-010-01	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	10/01/2022

Labeler - Best Innovation (695668556)

Registrant - Best Innovation (695668556)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	manufacture(83069-010)