Kopher Calming Ocean Sun

Manufacturer
Best Innovation | Cit Co., Ltd.
Effective date
2022-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:14

Label at a glance#

ProductKopher Calming Ocean Sun
Active ingredientOCTINOXATE, Zinc Oxide, OCTISALATE, Titanium Dioxide
Label structure10 sections

Indications and uses

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

Dosage and administration

■ 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

■ 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83069-010-022025-01-30C16284748780-12cef2736-8069-d83d-e063-dadaa90ab31fb5582558-eefb-436f-b388-22e86023be87

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83069-010-01Kopher Calming Ocean Sun50 mL in 1 CONTAINERCREAM501
83069-010-02Kopher Calming Ocean Sun1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83069-010KOPHER CALMING OCEAN SUN (ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE) CREAM [BEST INNOVATION]1Legacy NDC, 2 package rows20221029_b5582558-eefb-436f-b388-22e86023be87.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83069-01083069-010-01, 83069-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
399fb656-09ec-4193-ad3d-2440dca0b253b5582558-eefb-436f-b388-22e86023be872022-10-27WarningsExact identifier
spl id: 399fb656-09ec-4193-ad3d-2440dca0b253
spl set id: b5582558-eefb-436f-b388-22e86023be87

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.