RENARDBLANC MULTILAYER SUN BLOCK- octonoxate, octisalate, avobenzone, homosalate cream

RENARDBLANC MULTILAYER SUN BLOCK by

Drug Labeling and Warnings

RENARDBLANC MULTILAYER SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by Diamonie Seoul Cosmetic Co Ltd, Englewood Lab Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.00%
Octisalate 4.50%
Avobenzone 2.50%
Homosalate 2.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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

INGREDIENTS AND APPEARANCE

RENARDBLANC MULTILAYER SUN BLOCK 
octonoxate, octisalate, avobenzone, homosalate cream

Product 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)