PURIFYING OXYGENATING SERUM- glycerin, dimethicone cream

Purifying Oxygenating Serum by

Drug Labeling and Warnings

Purifying Oxygenating Serum 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 6.5%............. Skin Protectant

Dimethicone 0.75%.....Skin Protectant

USES

. helps to prevent dehydration of the skin.

- helps maintain the hydrolipidic layer of the skin.

USES

. helps to prevent the dehydration of the skin

. helps maintain the hydrolipidic layer of the skin

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

Whhen using this product do not get into eyes.

Children under 6 months: as a doctor.

WARNINGS

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

Warnings

Keep out of reach of children

Questions or comments?

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

Other Information

. keep the product in a cool and dry place

Directions

. apply every day gently onto clean face and neck

. can be used in the morning and/or night

. apply every day gently onto clean dace and neck

. can be used in the morning and/or night

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

Purifying Oxygenating Serum See below image

Skin Protectant

Helps to Prevent Dehydration of the Skin

Pure Ocygen 03 Facial Collection

50 ml 1.7 fl.oz.

Package Label

Please see image below. Package Label

INGREDIENTS AND APPEARANCE

PURIFYING OXYGENATING SERUM 
glycerin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20151-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.75 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	81.874 mg  in 1 mL
CERAMIDE NS DILAURATE (UNII: 1SL625KAAV)	0.0006 mg  in 1 mL
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)	0.006 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.001 mg  in 1 mL
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)	2 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 mg  in 1 mL
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)	0.75 mg  in 1 mL
BETAINE (UNII: 3SCV180C9W)	0.5 mg  in 1 mL
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)	0.22 mg  in 1 mL
TRIDECETH-6 (UNII: 3T5PCR2H0C)	0.22 mg  in 1 mL
RIBOSE, D- (UNII: 681HV46001)	0.2 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.096 mg  in 1 mL
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)	0.09 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.035 mg  in 1 mL
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)	0.015 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.001 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.001 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20151-056-02	1 in 1 CARTON	07/16/2015
1	NDC: 20151-056-01	50 mL in 1 BOTTLE, DISPENSING; 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	07/16/2015

Labeler - Casmara Cosmetics, SA (464973544)

Registrant - Casmara Cosmetics, SA (464973544)

Establishment
Name	Address	ID/FEI	Business Operations
Casmara Cosmetics, SA		464973544	manufacture(20151-056)