LIGHTENING CLARIFYING CONCENTRATED SERUM- 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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Lightening Clarifying concentrated serum

ACTIVE INGREDIENTS PURPOSE

Dimethicone 0.75%.................... Skin Protectant

Serum

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 to clean face, neck and chest and hands until the product has been absorbed.

. apply at night

. apply to clean face, neck and chest and hands until the product has been absorbed.

.apply at night

Uses

. helps maintain skyn younger and more radiant

Inactive Ingredients

Propylene Glycol, Water, Dimethyl Isosorbide, Octadecenedioic Acid, Daisy Flower Extract, Phenoxyethanol, Polymethyl methacrylate, Sodium polyacrylate, Xanthan gum, Cyclopentasiloxane, Trideceth-6, Tricaprylin, Licorice Root Extract, Ethylhexylglycerin, Tetrasodium glutamate diacetate, PEG/PPG-18/18 Dimethicone, BHT, Potassium sorbate

Uses

. helps to maintain the skin younger and more radiant

Package Label

Bottle

LIGHTENING CLARIFYING CONCENTRATED SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg  in 1 mL
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.09 mg  in 1 mL
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 3 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0075 mg  in 1 mL
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG) 2 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 48.935 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
TRICAPRYLIN (UNII: 6P92858988) 0.21 mg  in 1 mL
TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.225 mg  in 1 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.052 mg  in 1 mL
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) 0.828 mg  in 1 mL
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) 1.5 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T) 46 mg  in 1 mL
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) 0.75 mg  in 1 mL
LICORICE (UNII: 61ZBX54883) 0.126 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-103-021 in 1 BOTTLE, DISPENSING04/06/2017
1NDC:20151-103-0150 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 finalpart34703/29/2017
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-103)

Revised: 4/2017
Document Id: 4c7e2299-75b1-42ec-e054-00144ff8d46c
Set id: 4c7e2299-75b0-42ec-e054-00144ff8d46c
Version: 1
Effective Time: 20170406
 
Casmara Cosmetics, SA