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

SoonReborn Repair Essence by

Drug Labeling and Warnings

SoonReborn Repair Essence 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 ESSENCE- niacinamide, adenosine liquid 
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.

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ACTIVE INGREDIENTS

Niacinamide 2.0%
Adenosine 0.04%

INACTIVE INGREDIENTS

WATER, HYDROGENATED POLYDECENE, ISONONYL ISONONANOATE, GLYCERIN, OCTYLDODECANOL, 1,2-HEXANEDIOL, CARBOMER, DIPHENYL DIMETHICONE, HYDROXYACETOPHENONE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, TROMETHAMINE, AMODIMETHICONE, PROPYLENE CARBONATE, HYDROXYDECYL UBIQUINONE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, FRAGRANCE, DISODIUM EDTA, PHENOXYETHANOL, LACTOBACILLUS/PANAX GINSENG ROOT FERMENT FILTRATE, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, PROPANEDIOL, PORIA COCOS SCLEROTIUM EXTRACT, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, PANAX GINSENG ROOT EXTRACT, CAPRYLYL GLYCOL, TOCOPHEROL, XANTHAN GUM, 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 ESSENCE 
niacinamide, adenosine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81733-010
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)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81733-010-021 in 1 CARTON04/01/202112/30/2021
1NDC: 81733-010-01130 mL in 1 BOTTLE; 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(81733-010)

Revised: 5/2023
Document Id: 1f86a0f2-c14d-4e72-add4-dc5845944dcb
Set id: d7bddfaf-0819-4e67-b8dc-4f5bc432368b
Version: 2
Effective Time: 20230524