Label: PREMIUM ULTRA UV PURE SUN- octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stick
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Contains inactivated NDC Code(s)
NDC Code(s): 71609-0009-1 - Packager: Purecell Korea Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 8, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIUM ULTRA UV PURE SUN
octocrylene, ethylhexyl methoxycinnamate, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl salicylate, bis-ethylhexyloxyphenol methoxyphenyl triazine stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71609-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 7 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71609-0009-1 15 g in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2017 Labeler - Purecell Korea Co., Ltd. (694667185) Registrant - Purecell Korea Co., Ltd. (694667185) Establishment Name Address ID/FEI Business Operations Purecell Korea Co., Ltd. 557799448 label(71609-0009) Establishment Name Address ID/FEI Business Operations Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory 688235645 manufacture(71609-0009)