Label: PURITON PERFECT BRIGHTENING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81488-006-50 - Packager: Kadesh Incoporation 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 March 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
Adenosine, Aloe Leaf Extract, Alpha-isomethyl Ionone, Aluminum Hydroxide, Bamboo Leaf Extract, Benzyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Butylene Glycol, Butylphenyl Methylpropional, C12-C15 Alkyl Benzoate, C12-C20 Alkyl Glucoside, C14-C22 Alcohols, Caprylyl Dimethicone Ethoxy Glucoside, Caprylyl glycol, Cinnamyl Alcohol, Citronellol, Coumarin, Cyclomethicone 5, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Geraniol, Glucose, Glycerin, Glyceryl Stearate, Fragrance, 1,2-Hexanediol, Linalool, Monkey Bread Seed Extract, Niacinamide, Potassium Cetyl Phosphate, Propanediol, Silica, Silkworm Extract, Silk Amino Acids, Titanium Dioxide, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Witch Hazel Leaf Extract, Xanthan Gum
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SPL UNCLASSIFIED SECTION
SPF 50+
PA++++
puriton mineral water
+ silk amino acids
+ bambusa vulgaris water
+ adenosine
Distributed by
Kadesh Inc Corporation
201, 703 Eonju-ro, SK Leaders
View, Dogok-dong,
Gangnam-gu, Seoul, South
Korea 06274Manufactured by
Inc, iComax
87, Gajangsaneopseobuk-ro,
Osan-si, Gyeonggi-do 18102
Made in KoreaComposition of matter Patent No. 10-2022671
- Packaging
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INGREDIENTS AND APPEARANCE
PURITON PERFECT BRIGHTENING SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81488-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.75 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 90 mg in 1 g Inactive Ingredients Ingredient Name Strength ADENOSINE (UNII: K72T3FS567) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BAMBUSA VULGARIS LEAF (UNII: EMY54R518C) BENZYL BENZOATE (UNII: N863NB338G) BEMOTRIZINOL (UNII: PWZ1720CBH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) C14-22 ALCOHOLS (UNII: B1K89384RJ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CINNAMYL ALCOHOL (UNII: SS8YOP444F) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) COUMARIN (UNII: A4VZ22K1WT) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GERANIOL (UNII: L837108USY) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) LINALOOL, (+/-)- (UNII: D81QY6I88E) ADANSONIA DIGITATA SEED (UNII: 2936P60TPX) NIACINAMIDE (UNII: 25X51I8RD4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPANEDIOL (UNII: 5965N8W85T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BOMBYX MORI FIBER (UNII: 6LK42KUV6W) AMINO ACIDS, SILK (UNII: V0L00EX1IA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81488-006-50 1 in 1 BOX 03/01/2021 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2021 Labeler - Kadesh Incoporation Co,Ltd (694615354)
