LUXURY REVITALIZING MOISTURIZING CREAM- glycerin, dimethicone cream

Luxury Revitalizing Moisturizing Cream by

Drug Labeling and Warnings

Luxury Revitalizing Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by Casmara Cosmetics, SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS PURPOSE

Glycerin 5%..................... Skin Protectant

Dimethicone 4.2%............Skin Protectant

USES

. helps to prevent dehydration of the skin

. helps maintain the hydrolipidic layer of the skin

DIRECTIONS

. apply every day gently onto clean face and neck

. can be used in the morning and/or night.

DIRECTIONS

. apply every day gently onto clean face and neck

. can be used in the morning and/or night.

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 use and ask a doctor if rash occurs.

Keep out of reach of children.

When using this product do not get into eyes.

Children under 6 months: ask a doctor

WARNINGS

Children under 6 months: ask a doctor

WARNINGS

Keep out of reach of children

OTHER INFORMATION

keep the product in a cool and dry place.

INACTIVE INGREDIENTS

water, propylene glycol, butylene glycol dicaprate, ammonium acryloyldimethyltaurate/VP Copolymer, camellia japonica seed oil, betaine, phenoxyethanol, dimethicone crosspolymer, hydrolyzed wheat protein, ascorbic acid, alpha- tocopherol, perflunafene, ethylhexylglycerin, tetrasodium glutamate diacetate, limonene, Vitamina A Palmitate, tert-butyl alcohol, butylated hydroxyloluene, linaool, calcium sulfate, magnesium sulfate, copper sulfate, potassium sulfate, zinc sulfate, manganese sulfate, ferric sulfate

QUESTIONS OR COMMENTS?

+ 34 961 501 999 M-F 9:00 am to 5:00 pm

Luxury Revitalizing Moisturizing Cream

INGREDIENTS AND APPEARANCE

LUXURY REVITALIZING MOISTURIZING CREAM 
glycerin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	4.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)	1417 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.094 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	79.74 mg  in 1 mL
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)	0.5 mg  in 1 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40)	2.5 mg  in 1 mL
BUTYLENE GLYCOL DICAPRATE (UNII: 3Z317CA098)	2 mg  in 1 mL
BETAINE (UNII: 3SCV180C9W)	1 mg  in 1 mL
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)	0.8 mg  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R)	0.33 mg  in 1 mL
MAGNESIUM SULFATE (UNII: DE08037SAB)	0.00065 mg  in 1 mL
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)	1 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.1 mg  in 1 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.03 mg  in 1 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.03 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.01 mg  in 1 mL
LINALOOL, (+)- (UNII: F4VNO44C09)	0.006 mg  in 1 mL
CALCIUM SULFATE (UNII: WAT0DDB505)	0.003 mg  in 1 mL
BASIC COPPER SULFATE (UNII: CUP529P5NS)	0.0005 mg  in 1 mL
POTASSIUM SULFATE (UNII: 1K573LC5TV)	0.00025 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB)	0.00017 mg  in 1 mL
MANGANESE SULFATE (UNII: W00LYS4T26)	0.0001 mg  in 1 mL
FERRIC SULFATE (UNII: 3HWS7HF5XD)	0.00005 mg  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.031 mg  in 1 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.134 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-081-02	1 in 1 CARTON	02/21/2017
1	NDC: 20151-081-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/21/2017

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-081)