PURPLEU BAOBAB AND ROSE DEEP HYDRATION CREAM THERAPY- dimethicone cream 
Purple U Co., Ltd

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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90069-201

Active Ingredients

Dimethicone 0.3%

Purpose

Skin Protectant

Uses

Helps protectant the skin from outside environment

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

Warnings

Stop use and ask a doctor if rash occurs

Warnings

Keep out of reach of children. If productis swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use at any desired time. Scoop the desired amount of the luxurious hydration cream with the spatula that is provided with the cream. Then apply in an upward and outward motion to the face and it also can be applied on the neck and body.

Inactive ingredients

Water, Adansonia Digitata Fruit Extract, Glycerin, Butylene Glycol, Octyldodecanol, Cyclopentasiloxane, Glyceryl Stearate, Pentylene Glycol, Phenyl Trimethicone, Cetearyl Alcohol, Cetyl Alcohol, Cyclohexasiloxane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Rosa Damascena Flower Water, Copernicia Cerifera (Carnauba) Wax, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Adansonia Digitata Seed Oil, Camellia Japonica Seed Oil, Camellia Oleifera Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa(Turmeric) Root Extract, Ocimum Sanctum Leaf Extract, Pelargonium Graveolens Flower Oil, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ficus Carica (Fig) Fruit Extract, Ginkgo Biloba Nut Extract, Morus Alba Fruit Extract, Punica Granatum Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/ Hexarosinate, PEG-20 Methyl Glucose Sesquistearate, PEG/PPG-17/6 Copolymer, PEG-100 Stearate, Bis-Diglyceryl Polyacyladipate-2, Panthenol, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Sodium Polyacrylate Starch, Dimethicone/ Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Citronellol, Hexyl Cinnamal, Geraniol, Butylphenyl Methylpropional, Farnesol, Benzyl Benzoate, Amylcinnamyl Alcohol, Linalool

Package Label

100ml NDC: 90069-201-01 Label

PURPLEU BAOBAB AND ROSE DEEP HYDRATION CREAM THERAPY 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90069-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
FARNESOL (UNII: EB41QIU6JL)  
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HOLY BASIL LEAF (UNII: SCJ765569P)  
GINKGO BILOBA SEED (UNII: 8CQ734K3W7)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
TURMERIC (UNII: 856YO1Z64F)  
ROSEMARY (UNII: IJ67X351P9)  
WHITE MULBERRY (UNII: MN25R0HH5A)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
HYALURONIC ACID (UNII: S270N0TRQY)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DIPENTAERYTHRITYL HEXASTEARATE (UNII: WTF09990PK)  
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SHEA BUTTER (UNII: K49155WL9Y)  
ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)  
.ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
FIG (UNII: TGD87RII2U)  
POMEGRANATE (UNII: 56687D1Z4D)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROMETHAMINE (UNII: 023C2WHX2V)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
GERANIOL (UNII: L837108USY)  
BENZYL BENZOATE (UNII: N863NB338G)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90069-201-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/02/2020
Labeler - Purple U Co., Ltd (694823532)
Registrant - RECIPE CO., LTD (631158768)
Establishment
NameAddressID/FEIBusiness Operations
RECIPE CO., LTD631158768manufacture(90069-201)

Revised: 9/2020
Document Id: ae525362-16ba-3f13-e053-2995a90aa2dc
Set id: ae525362-16b9-3f13-e053-2995a90aa2dc
Version: 1
Effective Time: 20200902
 
Purple U Co., Ltd