Indications and uses
■ Helps prevent sunburn ■ Higher SPF gives more sunburn protection ■ Retains SPF after 80 minutes of activity in the water or sweating
■ Helps prevent sunburn ■ Higher SPF gives more sunburn protection ■ Retains SPF after 80 minutes of activity in the water or sweating
■ 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.
Ethylhexyl Methoxycinnamate 7.50%
Zinc Oxide 4.00%
Ethylhexyl Salicylate 3.00%
Titanium Dioxide (CI 77891) 1.60%
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)
Sunscreen
■ 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. If product is swallowed, get medical help or contact a Poison Control
■ Helps prevent sunburn
■ Higher SPF gives more sunburn protection
■ Retains SPF after 80 minutes of activity in the water or sweating
■ 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.
■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83069-010-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8069-d83d-e063-dadaa90ab31f | b5582558-eefb-436f-b388-22e86023be87 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83069-010-01 | Kopher Calming Ocean Sun | 50 mL in 1 CONTAINER | CREAM | 50 | 1 | |
| 83069-010-02 | Kopher Calming Ocean Sun | 1 in 1 CARTON | CREAM | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83069-010 | KOPHER CALMING OCEAN SUN (ETHYLHEXYL METHOXYCINNAMATE, ZINC OXIDE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE) CREAM [BEST INNOVATION] | 1 | Legacy NDC, 2 package rows | 20221029_b5582558-eefb-436f-b388-22e86023be87.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83069-010 | 83069-010-01, 83069-010-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| Zinc Oxide | SOI2LOH54Z | ACTIM |
| OCTISALATE | 4X49Y0596W | ACTIB |
| Titanium Dioxide | 15FIX9V2JP | ACTIB |
| Water | 059QF0KO0R | IACT |
| CYCLOMETHICONE 5 | 0THT5PCI0R | IACT |
| Butylene Glycol | 3XUS85K0RA | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 399fb656-09ec-4193-ad3d-2440dca0b253 | b5582558-eefb-436f-b388-22e86023be87 | 2022-10-27 | Warnings | 399fb656-09ec-4193-ad3d-2440dca0b253 b5582558-eefb-436f-b388-22e86023be87 |
Adverse event summaries are temporarily unavailable. Other product information remains available.