VITALIZING ENERGIZING MOISTURIZING CREAM- 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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Vitalizing Energizing Moisturizing Cream

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 until the product has been absorbed

. can be used in the morning and/or night

. apply every day gently onto clean dace and neck until the product has been absorbed

. can be used in the morning and/or night

Uses

. provides an intensive dose of hydration and energy

Inactive Ingredients

water, cyclopentasiloxane, steareth-21, avocado oil, squalane, PEG-8 distearate, steareth-2, phenoxyethanol, avena sativa (oak) kernel extract, creatine, carbomer, triethanolamine, parfum, ethylhexylglycerin, limonene, ubiquinone, tetrasodium glutamate diacetate, citric acid, sodium citrate, soluble collage, sodium hyaluronate, linalool, sodium benzoate, ascorbyl palmitate

Uses

. provides an intense dose of hydration and energy

ACTIVE INGREDIENTS PURPOSE

Glycerin 5%.................... Skin Protectant

Dimethicone 0.40%.........Skin Protectant

Box







See below image

Vitalizing Energizing Moisturizing Cream

Skin Protectant

Nourishing

Intensive Q 10 Hydro 24 h

Package Label

Please see image below. Package Label

Bottle

VITALIZING ENERGIZING MOISTURIZING CREAM 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 3 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.5 mg  in 1 mL
PEG-8 DISTEARATE (UNII: 7JNC8VN07M) 2 mg  in 1 mL
STEARETH-2 (UNII: V56DFE46J5) 2 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 78.27 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N) 0.3 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.104 mg  in 1 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
UBIQUINOL (UNII: M9NL0C577Y) 0.1 mg  in 1 mL
OAT KERNEL OIL (UNII: 3UVP41R77R) 0.52 mg  in 1 mL
LINALOOL, (+)- (UNII: F4VNO44C09) 0.019 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.045 mg  in 1 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.001 mg  in 1 mL
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) 0.025 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.02 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0125 mg  in 1 mL
CREATINE (UNII: MU72812GK0) 0.5 meq  in 1 mL
AVOCADO OIL (UNII: 6VNO72PFC1) 2.6 mg  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.027 mg  in 1 mL
SQUALANE (UNII: GW89575KF9) 2 mg  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mg  in 1 mL
STEARETH-21 (UNII: 53J3F32P58) 3 meq  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20151-089-021 in 1 BOTTLE, DISPENSING02/23/2017
1NDC:20151-089-0150 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 finalpart34702/23/2017
Labeler - Casmara Cosmetics, SA (464973544)
Registrant - Casmara Cosmetics, SA (464973544)
Establishment
NameAddressID/FEIBusiness Operations
Casmara Cosmetics, SA464973544manufacture(20151-089)

Revised: 2/2017
Document Id: 49334f91-f98c-41a1-e054-00144ff88e88
Set id: 42d73b7d-ff15-0a49-e054-00144ff8d46c
Version: 2
Effective Time: 20170223
 
Casmara Cosmetics, SA