Label: KORU PERFORMANCE SUNSCREEN SPF40- sunscreen lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 81129-001-01 - Packager: Koru Performance LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
-
Directions
• Apply liberally 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply
Immediately after towel drying
At least every 2 hours• Children under 6 months of age: ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with a Broad Spectrum SPF value of 15 or higher and other sun protection
measures including:
• limit time in the sun, especially from 10 am to 2 pm
• wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
-
Inactive Ingredients
Batilol, Butylene glycol, Ceresin, Cetyl alcohol, Cocoyl caprylocaprate, Dimethicone, Disteardimonium hectorite, Edetate disodium, Ethylhexylglycerin, Ethyl ferulate, Medium chain triglycerides, Neopentyl glycol dicaprate, Pentaerythrityl tetraethylhexanoate, Phenoxyethanol, Polyglyceryl-3 pentaricinoleate, Polyglyceryl-4 isostearate, Propanediol, Propanediol dicaprylate, Silicon dioxide, Sorbitan isostearate, Styrene/Acrylamide copolymer (MW 500000), Triethoxycaprylylsilane, Water
- Bottle Label
-
INGREDIENTS AND APPEARANCE
KORU PERFORMANCE SUNSCREEN SPF40
sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81129-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BATILOL (UNII: 39YR661C4U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ETHYL FERULATE (UNII: 5B8915UELW) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL ALCOHOL (UNII: 936JST6JCN) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82) CERESIN (UNII: Q1LS2UJO3A) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPANEDIOL (UNII: 5965N8W85T) DIMETHICONE (UNII: 92RU3N3Y1O) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81129-001-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/01/2021 Labeler - Koru Performance LLC (117749158) Establishment Name Address ID/FEI Business Operations TAKA USA Inc. dba Cosmetic Innovations 802860515 manufacture(81129-001)
