RENOVATING REGENERATING NOURISHING CREAM- glycerin cream

Renovating Regenerating Nourishing Cream by

Drug Labeling and Warnings

Renovating Regenerating Nourishing Cream by is a Otc medication manufactured, distributed, or labeled by Casmara Cosmetics, SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.

ASK DOCTOR

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

KEEP OUT OF REACH OF CHILDREN

. 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

OTHER SAFETY INFORMATION

. 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

DOSAGE & ADMINISTRATION

. 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

INACTIVE INGREDIENT

Water, Cetyl acetate, Avocado oil, Macadamia integrifolia seed oil, Egg yolk extract, Glyceryl stearate, Sorbitol, Acetylated lanolin, alcohol, Propylene glycol, Triethanolamine, 4-methylbenzylidene camphor, Phenylbenzimidazole sulfonic acid, Phenoxyethanol, Lecithin, Cethyl phosphate, Chestnut seed extract, Carbomer, Corn oil, Glycolic acid, Fragrance, Lactic acid, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Rosa moschata seed oil, Sodium chloride, Caprylyl glycol, BHT, Lysine hydrochloride, Glycinel Arginine, Alanine, Sodium hyaluronate, Mallow extract, Citric acid, Proline, Ascorbyl palmitate, Acetyl hexapeptide-8l Tocopherol, Potassium sorbate, Sodium benzoate, Rosemary leaf extract, Sunflower seed oil, Tricalcium phosphate

PURPOSE

. helps to prevent dehydration of the skin

. helps maintain the hydrolipidic layer of the skin

Active Ingredients

Glycerin 1.98%........................... Skin Protectant

PRINCIPAL DISPLAY PANEL

Renovating

Regenerating Nourishing Cream

Skin Protectant

Moisturizing

RGnerin Plus Texture

Facial Collection

INGREDIENTS AND APPEARANCE

RENOVATING REGENERATING NOURISHING CREAM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.98 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)	0.5 mg  in 1 mL
ROSA MOSCHATA OIL (UNII: J99W255AWF)	0.062 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.033 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S)	0.21 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.025 mg  in 1 mL
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)	0.022 mg  in 1 mL
GLYCINE (UNII: TE7660XO1C)	0.022 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N)	0.0034 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.0016 mg  in 1 mL
ROSEMARY (UNII: IJ67X351P9)	0.0012 mg  in 1 mL
CETYL PHOSPHATE (UNII: VT07D6X67O)	0.75 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.111 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	58.029 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.94 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.1 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.0025 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.2 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0016 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK)	1.6 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	1.65 mg  in 1 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)	0.75 mg  in 1 mL
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)	0.00011 mg  in 1 mL
ARGININE (UNII: 94ZLA3W45F)	0.011 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.1 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.008 mg  in 1 mL
PROLINE (UNII: 9DLQ4CIU6V)	0.0055 mg  in 1 mL
CETYL ACETATE (UNII: 4Q43814HXS)	11.31 mg  in 1 mL
AVOCADO OIL (UNII: 6VNO72PFC1)	7 mg  in 1 mL
SORBITOL (UNII: 506T60A25R)	2 mg  in 1 mL
MACADAMIA OIL (UNII: 515610SU8C)	4.99 mg  in 1 mL
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)	1.69 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)	0.5 mg  in 1 mL
ALANINE (UNII: OF5P57N2ZX)	0.011 mg  in 1 mL
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)	0.0099 mg  in 1 mL
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)	0.0025 mg  in 1 mL
CORN OIL (UNII: 8470G57WFM)	0.43 mg  in 1 mL
SUNFLOWER OIL (UNII: 3W1JG795YI)	0.0012 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	0.18 mg  in 1 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	2.4 mg  in 1 mL
EGG YOLK (UNII: 4IPS17B70T)	2.4 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.022 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-085-02	1 in 1 BOTTLE, DISPENSING	02/23/2017
1	NDC: 20151-085-01	50 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/12/2016

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-085)