NOURISHING 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 NOURISHING CREAM

USES

. helps to prevent dehydration of the skin

. heps maintain the hydrolipidic layer of the skin.

USES

.helps to precent dehydration of the skin

.helps maintain the hydrolipidic layer of the skin

ACTIVE INGREDIENTS

ACTIVE INGREDIENTS PURPOSE

Mineral Oil 20%.................. Skin protectant

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

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

Children under 6 months: ask a doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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.

OTHER INFORMATION

. keep the product in a cool and dry place

INACTIVE INGREDIENTS

Water, Macadamia ternifolia seed oil, Egg yolk extract, Glyceryl stearate, Phenoxyethanol, Lecithin , Cetyl phosphate, Triethanolamine, Carbomer, Fragrance, Sodium hyaluronate, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Perfluorodecalin, Jojoba seed oil, BHT, Ceramide NP, Sucrose Palmitate, Tocopherol, Xanthan gum, Sodium benzoate, Potassium sorbate, Ascorbyl palmitate

Bottle

QUESTIONS OR COMMENTS?

+ 34 961 501 999

M-F 9:00 am to 5:00 pm

PURIFYING OXYGENATING NOURISHING CREAM

bOX

Purifying Nourishing Cream

Purifying Nourishing Cream

Purifying Nourishing Cream

Box

NOURISHING CREAM 
mineral oil, glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL20 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MACADAMIA OIL (UNII: 515610SU8C) 5.99 mg  in 1 mL
EGG YOLK (UNII: 4IPS17B70T) 2 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.001 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0005 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.01 mg  in 1 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 59.7 mg  in 1 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.625 mg  in 1 mL
CETYL PHOSPHATE (UNII: VT07D6X67O) 0.625 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.6 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.4 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
PERFLUNAFENE (UNII: 54A06VV62N) 0.035 mg  in 1 mL
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) 0.015 mg  in 1 mL
CERAMIDE NS DILAURATE (UNII: 1SL625KAAV) 0.006 mg  in 1 mL
SUCROSE PALMITATE (UNII: 3OSQ643ZK5) 0.006 mg  in 1 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.003 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.001 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.001 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-084-021 in 1 CARTON02/22/2017
1NDC:20151-084-011 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/02/2015
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-084)

Revised: 2/2017
Document Id: 491e73ea-6f41-0b29-e054-00144ff88e88
Set id: 19e38c35-b132-2eb7-e054-00144ff8d46c
Version: 5
Effective Time: 20170222
 
Casmara Cosmetics, SA