PRIMEROSE WHITE MILKY CB- dimethicone, niacinamide, panthenol, adenosine cream

PRIMEROSE WHITE MILKY CB by

Drug Labeling and Warnings

PRIMEROSE WHITE MILKY CB by is a Otc medication manufactured, distributed, or labeled by Royal Springs Cosmetics USA, LLC, Royal Springs Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PRIMEROSE WHITE MILKY CB 
dimethicone, niacinamide, panthenol, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69888-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.025   in 80 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.02   in 80 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.005   in 80 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.0004   in 80 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69888-103-02	1 in 1 PACKAGE	02/13/2018
1	NDC: 69888-103-01	80 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/13/2018

Labeler - Royal Springs Cosmetics USA, LLC (079837692)

Registrant - Royal Springs Cosmetics USA, LLC (079837692)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Springs Cosmetics USA, LLC		079837692	relabel(69888-103)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Springs Cosmetic Co., Ltd.		689514344	manufacture(69888-103)