Kopher Calming Ocean Sun
FDA Label NDC 83069-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Best Innovation for the product Kopher Calming Ocean Sun (NDC 83069-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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