PRIMEROSE DOUBLE EFFECT EYE- niacinamide, 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.

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PRIMEROSE DOUBLE EFFECT EYE CREAM

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

eye cream

PRIMEROSE DOUBLE EFFECT EYE 
niacinamide, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69888-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 30 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.0004   in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69888-105-021 in 1 PACKAGE01/15/2019
1NDC:69888-105-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/15/2016
Labeler - Royal Springs Cosmetics USA, LLC (079837692)
Registrant - Royal Springs Cosmetics USA, LLC (079837692)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetics USA, LLC079837692relabel(69888-105)
Establishment
NameAddressID/FEIBusiness Operations
Royal Springs Cosmetic Co.,Ltd.689514344manufacture(69888-105)

Revised: 1/2019
Document Id: 7f898b2d-7129-94d7-e053-2991aa0adc48
Set id: e5904a5a-61d1-4424-9875-c1831d0dfcbd
Version: 3
Effective Time: 20190115
 
Royal Springs Cosmetics USA, LLC