OTC - ACTIVE INGREDIENT SECTION
Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
PREMIUM ULTRA UV PURE SUN
- Manufacturer
- Purecell Korea Co., Ltd. | Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory
- Effective date
- 2017-08-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:14:09
Label at a glance#
ProductPREMIUM ULTRA UV PURE SUN
Active ingredientOCTINOXATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, OCTISALATE, BEMOTRIZINOL, OCTOCRYLENE
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Water, Butylene Glycol, etc.
OTC - PURPOSE SECTION
Sunscreen
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
keep out or reach of the children
INDICATIONS & USAGE SECTION
During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skn that will be exposed to ultraviolet sunlight.
WARNINGS SECTION
Do not use on damaged or broken skin.
When using this product
• Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use if following symptoms occur. (Continuing in usage may increase symptoms, ask doctor.)
1) If any red spots, swelling, itching, or skin irritation develops.
2) If direct sunlight causes irritation
Keep out of reach of children
• Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control
Center right away.
Store at room temperature
•
Close lid after use – possibility of contamination may exists if displaced contents are replaced back to container.
DOSAGE & ADMINISTRATION SECTION
for external use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71609-0009-1 | 2024-12-05 | C162847 | 48780-1 | ab0e2407-3205-f274-e053-dbdaa90a6471 | 56379c3c-8622-0508-e054-00144ff8d46c |
| 71609-0009-1 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3205-f274-e053-dbdaa90a6471 | 56379c3c-8622-0508-e054-00144ff8d46c |
| 71609-0009-1 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3205-f274-e053-dbdaa90a6471 | 56379c3c-8622-0508-e054-00144ff8d46c |
| 71609-0009-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3205-f274-e053-dbdaa90a6471 | 56379c3c-8622-0508-e054-00144ff8d46c |
Products#
Every source-derived product name is available through these pages.
- PREMIUM ULTRA UV PURE SUN
- Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine
- OCTINOXATE
- DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE
- OCTISALATE
- BEMOTRIZINOL
- WATER
- OCTOCRYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71609-0009 | 71609-0009-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE | ANQ870JD20 | ACTIB |
| OCTISALATE | 4X49Y0596W | ACTIB |
| BEMOTRIZINOL | PWZ1720CBH | ACTIB |
| WATER | 059QF0KO0R | IACT |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 288161d6-1341-809d-e063-6294a90a2b55 | 56379c3c-8622-0508-e054-00144ff8d46c | 2024-12-05 | Warnings | 56379c3c-8622-0508-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.