PURIFYING OXYGENATING MOISTURIZING CREAM- mineral oil, 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.

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PURIFYING OXYGENATING MOISTURIZING CREAM

DIRECTIONS

. apply every day gently onto clean face and neck

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

ACTIVE INGREDIENTS PURPOSE

Mineral Oil 20%..................Skin Protectant

Glycerin 6.5%..................... Skin Protectant

Bottle

WARNINGS

Children under 6 months: ask a doctor

WARNINGS

Keep out of reach of children

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.

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

OTHER INFORMATION

keep the product in a cool and dry place.

INACTIVE INGREDIENTS

water, peg-40 castor oil, phenoxyethanol, sodium polyacrylate, betaine, cyclopentasiloxane, trideceth-6, ribose, fragrance, ethylhexylglycerin, tetrasodium glutamate diacetate, peg/ppg- 18/18 dimethicone, perfluorodecalin, simmondsia chinensis (jojoba) seed oil, ceramide np, sucrose palmitate, xanthan gum, sodium benzoate, potassium sorbate.

QUESTIONS OR COMMENTS?

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

Purifying Oxygenating Moisturizing Cream

Box

PURIFYING OXYGENATING MOISTURIZING CREAM 
mineral oil, glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.5 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EGG YOLK (UNII: 4IPS17B70T) 2 mg  in 1 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.62 mg  in 1 mL
CETYL PHOSPHATE (UNII: VT07D6X67O) 0.625 mg  in 1 mL
MACADAMIA OIL (UNII: 515610SU8C) 4.99 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.6 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.45 mg  in 1 mL
RIBOSE, D- (UNII: 681HV46001) 0.2 mg  in 1 mL
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) 0.1 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.002 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0005 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.011 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 63.59 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-083-021 in 1 CARTON02/23/2017
1NDC:20151-083-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/23/2017
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-083)

Revised: 2/2017
Document Id: 491e73ea-6f30-0b29-e054-00144ff88e88
Set id: 19f02f34-4aa0-53d7-e054-00144ff8d46c
Version: 5
Effective Time: 20170222
 
Casmara Cosmetics, SA