RENOVATING REGENERATING SERUM- glycerin cream 
Casmara Cosmetics, SA

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.

----------

Renovating Regenerating Serum.

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

Whhen using this product do not get into eyes.

Children under 6 months: as a doctor.

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

. keep out of reach of children

Questions or Comments?

Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

. keep the product in a cool and dry place

Directions

. apply every day gently onto clean face and neck

. can be used in the morning and/or night

. apply every day gently onto clean dace and neck

. can be used in the morning and/or night

Uses

. helps to prevent dehydration of the skin.

. helps maintain the hydrolipidic layer of the skin

water, propylene glycol, horse chestnut extract, PEG-25 castor oil, triethanolamine, phenoxyethanol, alcohol, PVM/MA Decadiene crospolymer, chestnut seed extract, glycolic acid, fragrance, lactic acid, polysorbate 20, tocopherol, ethylhexylglycerin, tetrasodium glutamate diacetate, caprylyl glycol, potassium thiocyanate, retinyl palmitate, inositol, calcium pantothenate, linoleic acid, lactoferrin, lactoperoxidase, disodium phosphate, biotin, acetyl hexapeptide-8, glucose pentaacetate, glucose oxidase, potassium phosphate

. helps to prevent dehydration of the skin

. helps maintain the hydrolipidic layer of the skin

Active Ingredients

Glycerin 0.25%........................... Skin Protectant

Serum 1

Renovating

Regenerating Serum

Skin Protectant

Moisturizing

RGnerin Enzyme

Facial Collection

Serum 2

RENOVATING REGENERATING SERUM 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 1.875 mg  in 1 mL
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD) (UNII: 389H2R62BD) 0.8 mg  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) 0.3 mg  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.15 mg  in 1 mL
LINOLEIC ACID (UNII: 9KJL21T0QJ) 0.027 mg  in 1 mL
LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49) 0.015 mg  in 1 mL
BIOTIN (UNII: 6SO6U10H04) 0.005 mg  in 1 mL
CALCIUM PANTOTHENATE, (-)- (UNII: 6IY177DF2V) 0.027 mg  in 1 mL
POTASSIUM THIOCYANATE (UNII: TM7213864A) 0.037 mg  in 1 mL
LACTOFERRIN, BOVINE (UNII: KG21X1090A) 0.025 mg  in 1 mL
GLUCOSE PENTAACETATE (UNII: 3040885R4N) 0.0035 mg  in 1 mL
GLUCOSE OXIDASE (UNII: 0T8392U5N1) 0.001 mg  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.027 mg  in 1 mL
SPANISH CHESTNUT (UNII: 2MT5XMR2YW) 1.875 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) 0.21 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.05 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.106 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 72.75 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.915 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.15 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N) 0.2 mg  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) 0.001 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 1 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 18 mg  in 1 mL
SODIUM PHOSPHATE (UNII: SE337SVY37) 0.0115 mg  in 1 mL
INOSITOL (UNII: 4L6452S749) 0.0275 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) 0.875 mg  in 1 mL
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) 0.005 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT) 0.18 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-068-021 in 1 BOTTLE, DISPENSING05/13/2016
1NDC:20151-068-0150 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/13/2016
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-068)

Revised: 11/2016
Document Id: 403911b5-bd00-3734-e054-00144ff8d46c
Set id: 32bdd122-8164-4f2d-e054-00144ff8d46c
Version: 2
Effective Time: 20161101
 
Casmara Cosmetics, SA