SoonReborn Repair by Newborn Korea Co., Ltd. / Kolmar Korea Co.,LTD. Gwanjeong Factory

SoonReborn Repair by

Drug Labeling and Warnings

SoonReborn Repair by is a Otc medication manufactured, distributed, or labeled by Newborn Korea Co., Ltd., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOONREBORN REPAIR- niacinamide, adenosine cream 
Newborn Korea Co., Ltd.

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.

----------

ACTIVE INGREDIENTS

Niacinamide 2.0%
Adenosine 0.04%

INACTIVE INGREDIENTS

WATER, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, GLYCERIN, CYCLOHEXASILOXANE, GLYCERYL STEARATE, CETEARYL ALCOHOL, BUTYLENE GLYCOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL ETHER, POLYGLYCERYL-10 LAURATE, BEESWAX, 1,2-HEXANEDIOL, SODIUM STEAROYL GLUTAMATE, JOJOBA ESTERS, PHENOXYETHANOL, LAMINARIA JAPONICA EXTRACT, ECLIPTA PROSTRATA LEAF EXTRACT, BISABOLOL, TRANEXAMIC ACID, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, HYDROXYACETOPHENONE, ALCOHOL, ETHYLHEXYLGLYCERIN, LACTOBACILLUS/PANAX GINSENG ROOT FERMENT FILTRATE, FRAGRANCE, FRUCTOOLIGOSACCHARIDES, DISODIUM EDTA, HYDROGENATED LECITHIN, BETA-GLUCAN, SODIUM LAURATE, XANTHAN GUM, POLYGLYCERIN-3, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PENTYLENE GLYCOL, PHELLODENDRON AMURENSE BARK EXTRACT, HYDROLYZED HYALURONIC ACID, LAURIC ACID, DEXTRIN, THEOBROMA CACAO (COCOA) SEED EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, SOPHORA FLAVESCENS ROOT EXTRACT, RHEUM PALMATUM ROOT/STALK EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, PROPANEDIOL, PORIA COCOS SCLEROTIUM EXTRACT, TOCOPHEROL, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, PANAX GINSENG ROOT EXTRACT, CAPRYLYL GLYCOL, HYDROXYDECYL UBIQUINONE, SODIUM HYALURONATE

PURPOSE

Skin brightening
Anti wrinkle

WARNINGS

For external use only
1. If there is any red spot, swallowing or itching by direct sunlight or if there is any other adverse effect during or after cosmetics use, consult with a doctor.
2. Refrain from using on the injured area
3. Precaution for storage and handling
a) Keep out of reach of children
b) Keep away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps brighten skin tone.
■ Helps improve wrinkle problem.

Directions

■ Apply an appropriate amount evenly on the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

SOONREBORN REPAIR 
niacinamide, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81733-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.0 g  in 100 mL
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81733-020-021 in 1 CARTON04/01/202112/30/2021
1NDC: 81733-020-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/202112/30/2021
Labeler - Newborn Korea Co., Ltd. (695738446)
Registrant - Newborn Korea Co., Ltd. (695738446)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(81733-020)

Revised: 5/2023