Label: RENARDBLANC MULTILAYER SUN BLOCK- octonoxate, octisalate, avobenzone, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72073-001-01, 72073-001-02 - Packager: Diamonie Seoul Cosmetic 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 February 5, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours
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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Dimethicone, Polyacrylate-13, Cetearyl Glucoside, Sodium Polyacrylate, PEG-100 Stearate, Glyceryl Stearate, Polyisobutene, Panthenol, Ethylhexylglycerin, Allantoin, Polysorbate 20, Stearyl Alcohol, Cetyl Alcohol, Glacier Water, Cirsium (Thistle) Flower/Leaf/Stem Extract, Glycerin, 1,2-Hexanediol, Zea, Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Corn Starch Octenylsuccinate, Butyrospermum Parkii (Shea) Butter Extract, Phenylethyl Resorcinol, Cocamidopropyl Dimethylamine, Lactic Acid, Palmitoyl Tripeptide-5, Hydrated Silica, Disodium EDTA, Phenoxyethanol, Fragrance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RENARDBLANC MULTILAYER SUN BLOCK
octonoxate, octisalate, avobenzone, homosalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72073-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.6 mg in 60 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.7 mg in 60 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mg in 60 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1.2 mg in 60 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BEMOTRIZINOL (UNII: PWZ1720CBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) DIMETHICONE (UNII: 92RU3N3Y1O) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) PEG-100 Stearate (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) PANTHENOL (UNII: WV9CM0O67Z) Ethylhexylglycerin (UNII: 147D247K3P) ALLANTOIN (UNII: 344S277G0Z) POLYSORBATE 20 (UNII: 7T1F30V5YH) Stearyl Alcohol (UNII: 2KR89I4H1Y) Cetyl Alcohol (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) STARCH, CORN (UNII: O8232NY3SJ) SHEA BUTTER (UNII: K49155WL9Y) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) HYDRATED SILICA (UNII: Y6O7T4G8P9) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72073-001-02 1 in 1 CARTON 02/05/2018 1 NDC:72073-001-01 60 mL in 1 CONTAINER; 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 02/05/2018 Labeler - Diamonie Seoul Cosmetic Co Ltd (694502893) Registrant - Diamonie Seoul Cosmetic Co Ltd (694502893) Establishment Name Address ID/FEI Business Operations Englewood Lab Inc 690104005 manufacture(72073-001)
