Re20 Advanced Wrinkle Control BB Cream by Dong Sung Bio Pharm. Co., Ltd. / Dong Sung World Wide USA, Inc. 42361-203 Drug Facts

Re20 Advanced Wrinkle Control BB Cream by

Drug Labeling and Warnings

Re20 Advanced Wrinkle Control BB Cream by is a Otc medication manufactured, distributed, or labeled by Dong Sung Bio Pharm. Co., Ltd., Dong Sung World Wide USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RE20 ADVANCED WRINKLE CONTROL BB CREAM BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide cream 
Dong Sung Bio Pharm. Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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42361-203 Drug Facts

Drug Facts

Titanium Dioxide 9.9%

Zinc Oxide 6.3%

Drug Facts

Sunscreen

Uses

Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)

Warnings

For external use only. Do not use on damaged or broken skin. Discontinue use if signs of irritation or rash appear. Avoid contact with eyes. Wash off immediately with cold water if product comes in contact with eyes. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. and wear long-sleeved shirts, pants, hats and sunglasses. Re20 Foam Cleanser contains iodopropynyl butylcarbamate (IPBC) and is not to be used for children under 3 years.

Allergy alert: Contains iodopropynyl butylcarbamate (IPBC).

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

At the very first stage of make-up, apply liberally on face to cover the entire facial area and lightly go over parts where extra cover-up is needed with detailed perfection. Apply 15 minutes before sun exposure. For added protection, reapply at least every 2 hours, after swimming, towel drying or extended sun exposure. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-8, Sodium Chloride, Arbutin, Caprylic/Capric Triglyceride, Diphenylsiloxy Phenyl Trimethicone , Natto Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Macadamia Integrifolia Seed Oil, Glycyrrhiza Inflata Root Extract, Hydrolyzed Collagen, Hydrolyzed Silk, Orchid Root Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Sorbitan Olivate, Sorbitan Isostearate, Polyglyceryl-4 Isostearate, Hexyl Laurate, Triethoxycaprylylsilane, Talc, Stearalkonium Hectorite, Beeswax, Propylene Carbonate , Magnesium Aluminum Silicate, Adenosine, Disodium EDTA, Chlorphenesin, Methylparaben, Butylparaben, Propylparaben, Fragrance, Iron Oxides (CI 77491, CI 77491, CI 77499)

Re20

Advanced Wrinkle Control BB Cream

BROAD SPECTRUM SPF 50

3 in 1

MULTI-FUNCTIONAL WEIGHTLESS BB CREAM THAT HELPS TO BRIGHTEN SKIN COMPLEXION,

CONTROL FINE WRINKLE LINES AND PREVENT SUNBURN

Re20 BB carton image

RE20 ADVANCED WRINKLE CONTROL BB CREAM  BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42361-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE99 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION63 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ADENOSINE (UNII: K72T3FS567)  
LICORICE (UNII: 61ZBX54883)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
JOJOBA OIL (UNII: 724GKU717M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ARBUTIN (UNII: C5INA23HXF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MACADAMIA OIL (UNII: 515610SU8C)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42361-203-011 in 1 CARTON12/18/2017
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/18/201712/31/2019
Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)
Registrant - Dong Sung World Wide USA, Inc. (784969219)
Establishment
NameAddressID/FEIBusiness Operations
Dong Sung Bio Pharm. Co., Ltd.687811661label(42361-203)

Revised: 6/2019
 
Dong Sung Bio Pharm. Co., Ltd.