PRIMEROSE DOUBLE EFFECT EYE- niacinamide, adenosine cream

PRIMEROSE DOUBLE EFFECT EYE by

Drug Labeling and Warnings

PRIMEROSE DOUBLE EFFECT EYE 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]

Niacinamide (2%) Adenosine (0.04%) 

skin protectant

Keep out of reach of children  Do not swallow. In case of accidental ingestion, seek professional assistance.

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 After using Essence Skin, put adequate amount into palm of hand, and softly rub onto face and neck.

Water, Butylene Glycol, Glycerin, Helianthus annuus(sunflower)seed oil, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl ethylhexanoate, Sodium hyaluronate, Dimethicone/vinyl dimethicone crosspolymer, Macadamia integrifolia seed Oil, Carprylic/capric triglyceride, Silica, Trehalose, Beeswax, Hydrogenated polyisobutene, Glyceryl stearate, Lactobacillus/Portulaca oleracea Ferment Filtrate, Soybean Extract Ferment Filtrate, Punica Granatum Fruit Ferment Extract, Phellius Baumiimycelium, Panax Ginseng Root Ferment Extract Filtrate, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata(Lichen)Extract Root Extract, Glyceryl acrylate/acrylic acid copolymer Propylene glycol, PEG-100 stearate, Glycol stearate SE, Hydrogenated lecithin, Stearic acid, Hydrogenated olive oil, Olea europaea (olive) unsaponifiables, Dimethicone, Polysorbate-60, Butyspermumpurkii(shea butter),Glyceryl carprylate, Cetearyl alcohol, Acrylate/C10-30 alkyl/acrylatecrosspolymer, Arginine, Lactobacillus Ferment/Glycrrgiza Glabra Root Extract, Morus Alba Stem Extract, Bambusa Vulgaris Shoot Extract, Luffa Cylindrica Fruit Extract, Pueraria Lobata Root Extract, Biosaccharide gum-1,Tocopheryl acetate, Yellow 4, Yellow 5, Hydrolyzed peaprotein, Lecithin, Squalane, Phytosterols, Ceramide 3, Fragrance, Beta-glucan, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Pyridoxyne hydrochloride, Maltodextrin, Amylodextrin, Sodium EDTA, Sodium metabisulfite

PRIMEROSE DOUBLE EFFECT EYE CREAM

INGREDIENTS AND APPEARANCE

PRIMEROSE DOUBLE EFFECT EYE 
niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69888-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.02   in 30 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.0004   in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
MACADAMIA OIL (UNII: 515610SU8C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
PULSATILLA KOREANA ROOT (UNII: FY35I16MPL)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCOL STEARATE (UNII: 0324G66D0E)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARGININE (UNII: 94ZLA3W45F)
MORUS ALBA STEM (UNII: 05Y42QCG2T)
BAMBUSA VULGARIS STEM (UNII: SMR633LHTC)
LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
SQUALANE (UNII: GW89575KF9)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CERAMIDE NP (UNII: 4370DF050B)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69888-105-02	1 in 1 PACKAGE	01/15/2019
1	NDC: 69888-105-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/15/2016

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(69888-105)

Establishment
Name	Address	ID/FEI	Business Operations
Royal Springs Cosmetic Co.,Ltd.		689514344	manufacture(69888-105)