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

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 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

Image of carton

KOPHER CALMING OCEAN SUN 
ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83069-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.50 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.0 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.60 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83069-010-021 in 1 CARTON10/01/2022
1NDC:83069-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2022
Labeler - Best Innovation (695668556)
Registrant - Best Innovation (695668556)
Establishment
NameAddressID/FEIBusiness Operations
Cit Co., Ltd.690081646manufacture(83069-010)

Revised: 10/2022
Document Id: 399fb656-09ec-4193-ad3d-2440dca0b253
Set id: b5582558-eefb-436f-b388-22e86023be87
Version: 1
Effective Time: 20221027
 
Best Innovation