RENOVATING REGENERATING MOISTURIZING CREAM- glycerin cream

Renovating Regenerating Moisturizing Cream by

Drug Labeling and Warnings

Renovating Regenerating Moisturizing 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, Glyceryl stearate, Egg yolk extract, Triethanolamine, Propylene glycol, Phenylbenzimidazole sulfonic acid, 4-methylbenzylidene camphor, Acetylated lanolin alcohol, Phenoxyethanol, Lecithin, Cetyl phosphate, Carbomer, Corn oil, Chestnut seed extract, Lactic acid, Glycolic acid, Tetrasodium glutamate diacetate, Ethylhexylglycerin, Fragrance, Rosa moschata seed oil, Sodium chloride, BHT, Lysine hydrochloride, Glycine, Caprylyl glycol, Sodium hyaluronate, Arginine, Alanine, Mallow extract, Citric acid, Proline, Ascorbyl palmitate, Acetyl hexapeptide-8, 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 7.80%........................... Skin Protectant

PRINCIPAL DISPLAY PANEL

Renovating

Regenerating Moisturizing Cream

Skin Protectant

Moisturizing

RGnerin Hydro Texture

Facial Collection

INGREDIENTS AND APPEARANCE

RENOVATING REGENERATING MOISTURIZING CREAM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	7.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)	0.4 mg  in 1 mL
ROSA MOSCHATA OIL (UNII: J99W255AWF)	0.062 mg  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.03 mg  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S)	0.21 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.02 mg  in 1 mL
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)	0.02 mg  in 1 mL
GLYCINE (UNII: TE7660XO1C)	0.02 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N)	0.0023 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.0015 mg  in 1 mL
ROSEMARY (UNII: IJ67X351P9)	0.0012 mg  in 1 mL
CETYL PHOSPHATE (UNII: VT07D6X67O)	0.875 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.101 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	61.36 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.93 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.103 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.002 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.1 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0015 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK)	1.7 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	1.5 mg  in 1 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)	0.875 mg  in 1 mL
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)	0.0001 mg  in 1 mL
ARGININE (UNII: 94ZLA3W45F)	0.01 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.1 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.007 mg  in 1 mL
PROLINE (UNII: 9DLQ4CIU6V)	0.005 mg  in 1 mL
CETYL ACETATE (UNII: 4Q43814HXS)	7.83 mg  in 1 mL
AVOCADO OIL (UNII: 6VNO72PFC1)	4 mg  in 1 mL
MACADAMIA OIL (UNII: 515610SU8C)	3.99 mg  in 1 mL
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)	1.17 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)	0.5 mg  in 1 mL
ALANINE (UNII: OF5P57N2ZX)	0.01 mg  in 1 mL
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)	0.009 mg  in 1 mL
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)	0.002 mg  in 1 mL
CORN OIL (UNII: 8470G57WFM)	0.4375 mg  in 1 mL
SUNFLOWER OIL (UNII: 3W1JG795YI)	0.0012 mg  in 1 mL
LACTIC ACID (UNII: 33X04XA5AT)	0.27 mg  in 1 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	2.8 mg  in 1 mL
EGG YOLK (UNII: 4IPS17B70T)	2.8 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: 20151-086-02	1 in 1 BOTTLE, DISPENSING	02/23/2017
1	NDC: 20151-086-01	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	02/23/2017

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-086)