LUXURY REVITALIZING MOISTURIZING CREAM- glycerin, dimethicone 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.

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LUXURY REVITALIZING MOISTURIZING CREAM

ACTIVE INGREDIENTS PURPOSE

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

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

Bottle

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

Box

QUESTIONS OR COMMENTS?

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

Luxury Revitalizing Moisturizing Cream

Luxury moisturizer bottle

LUXURY REVITALIZING MOISTURIZING CREAM 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-081-021 in 1 CARTON02/21/2017
1NDC:20151-081-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/21/2017
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-081)

Revised: 2/2017
Document Id: 4911f361-c835-6f13-e054-00144ff8d46c
Set id: 308626e2-9fa1-4e04-e054-00144ff8d46c
Version: 4
Effective Time: 20170221
 
Casmara Cosmetics, SA