PURIFYING OXYGENATING MOISTURIZING CREAM- mineral oil, glycerin cream

Purifying Oxygenating Moisturizing Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

PURIFYING OXYGENATING MOISTURIZING CREAM 
mineral oil, glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	6.5 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	17 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-083-02	1 in 1 CARTON	02/23/2017
1	NDC: 20151-083-01	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	02/23/2017

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-083)