PRIMEROSE WHITE MILKY CB- dimethicone, niacinamide, panthenol, adenosine cream 
Royal Springs Cosmetics USA, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

PRIMEROSE WHITE MILKY CB CREAM

Active ingredients

Dimethicone (2.5%)
Niacinamide (2%)
Panthenol (0.5%)
Adenosine (0.04%)

Purpose

skin protectant

Keep out of reach of children

- Do not swallow. In case of accidental ingestion, seek professional assistance.

Uses

Skin brightening and wrinkle care. Keep skin soft and smooth.

Warnings

For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on skin develops and lasts.
Store at room temperature

Directions

Use for final step of skin care. Apply 1g amount in the palm of hand per application. Rub into skin and pat lightly.

Inactive ingredients

Water, Butylene Glycol, Macadamia integrifolia seed oil, Sodium hyaluronate, Glycerin, Cyclohexasiloxane, Cyclopentasiloxane, Sodium Acrylate/Acryloyldimethyltaurate Copolymer, Isohexadecane, Polysorbate 80, Cetyl dimethicone, Cetyl ethylhexanoate, Olea europaea (olive) fruit oil, Titanium Dioxide, Dimethicone/Dimethicone Crosspolymer, Aloe Barbadensis Leaf Extract, Glyceryl Stearate, Cetyl PEG/PPG-10/1 Dimethicone, Hydrolyzed peaprotein, Lecithin, Squalane, Phytosterols, Ceramide 3, Butyspermumpurkii(shea butter), Betaine, Caprylyl Glycol, Allantoin, Beta-Glucan, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Disodium EDTA

PRIMEROSE WHITE MILKY CB CREAM

white milky

PRIMEROSE WHITE MILKY CB 
dimethicone, niacinamide, panthenol, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.025   in 80 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 80 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.005   in 80 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.0004   in 80 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MACADAMIA OIL (UNII: 515610SU8C)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
SQUALANE (UNII: GW89575KF9)  
CERAMIDE 3 (UNII: 4370DF050B)  
SHEA BUTTER (UNII: K49155WL9Y)  
BETAINE (UNII: 3SCV180C9W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69888-103-021 in 1 PACKAGE02/13/2018
1NDC:69888-103-0180 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/13/2018
Labeler - Royal Springs Cosmetics USA, LLC (079837692)
Registrant - Royal Springs Cosmetics USA, LLC (079837692)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetics USA, LLC079837692relabel(69888-103)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetic Co., Ltd.689514344manufacture(69888-103)

Revised: 1/2019
Document Id: 7f898b2d-7112-94d7-e053-2991aa0adc48
Set id: d22d0785-c0c8-4c6b-b088-9f4f9435e49b
Version: 8
Effective Time: 20190115
 
Royal Springs Cosmetics USA, LLC