PURIFYING OXYGENATING SERUM- 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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Purifying Oxygenating Serum

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.

Purifying bottle

Package Label

Please see image below. Package Label

Purifying Package

PURIFYING OXYGENATING SERUM 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.75 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-056-021 in 1 CARTON07/16/2015
1NDC:20151-056-0150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/16/2015
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-056)

Revised: 11/2016
Document Id: 4228a0cb-dacb-6765-e054-00144ff8d46c
Set id: 16b28e37-efff-23a8-e054-00144ff88e88
Version: 5
Effective Time: 20161125
 
Casmara Cosmetics, SA