CARECELLA VELVET COVER BB CREAM- dimethicone, octinoxate, titanium dioxide, zinc oxide cream 
General Bio 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.

----------

CareCella Velvet Cover BB Cream

Drug Facts

Active ingredients

Dimethicone 1%

Octinoxate 5%

Titanium Dioxide 7.6%

Zinc Oxide 0.98%

Purpose

Skin protection

Sunscreen

Uses

• Temporarily protects chapped or cracked skin

• Helps prevent sunburn

Warnings

For external use only

Do not use  • on damaged or broken skin.

When using this product  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if  • rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply generously and evenly 15 minutes before sun exposure and as needed
• Children under 6 months of age : Ask a doctor
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
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.
   • wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

Adenosine, Allantoin, Aluminum Hydroxide, Beeswax, Biosaccharide Gum-4, Bisabolol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Diisostearyl Malate, Fragrance, 1,2-Hexanediol, Iron Oxides (CI 77491, CI 77492 & CI 77499), Isoamyl p-Methoxycinnamate, Isopropyl Palmitate, Magnesium Stearate, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Mica (CI 77019), Microcrystalline Wax, Panthenol, Pentylene Glycol, Polyglyceryl-4 Isostearate, Propylene Glycol, Quaternium-18 Bentonite, Sea daffodil (Pancratium Maritimum) Extract, Shea (Butyrospermum parkii) Butter, Tocopheryl Acetate (Vitamin E acetate), Triethoxycaprylylsilane, Water

Other information

• protect the product in this container from excessive heat and direct sun.

Questions or comments?

Call +1-213-568-3732
Monday-Friday 9 a.m.-6 p.m. Pacific Time
You may also report serious side effects to this phone number

SUNSCREEN SKIN PROTECTANT CREAM

SPF 37 / PA++

UVA/UVB PROTECTION

BROAD SPECTRUM

All in One

Multi Action

PROTECT AND COVER

Distributed by GCOOP USA CORP. 1032 S. Crenshaw Blvd. #C-2 2ND Floor Los Angeles, CA 90019 Visit at us.gcoop.com

Made in Korea

Packaging

BBcrmlbl

CARECELLA  VELVET COVER BB CREAM
dimethicone, octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69422-1303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.98 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ADENOSINE (UNII: K72T3FS567)  
ALLANTOIN (UNII: 344S277G0Z)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
LEVOMENOL (UNII: 24WE03BX2T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
AMILOXATE (UNII: 376KTP06K8)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PANTHENOL (UNII: WV9CM0O67Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENTOQUATAM (UNII: 7F465U79Q1)  
PANCRATIUM MARITIMUM WHOLE (UNII: 2U9AFK127O)  
SHEA BUTTER (UNII: K49155WL9Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (Yellowish brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69422-1303-11 in 1 BOX12/19/2017
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/19/201709/30/2019
Labeler - General Bio Co., Ltd. (688299527)

Revised: 10/2019
 
General Bio Co., Ltd.