CareCella Velvet Cover BB Cream

CareCella by

Drug Labeling and Warnings

CareCella by is a Otc medication manufactured, distributed, or labeled by General Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

CARECELLA  VELVET COVER BB CREAM
dimethicone, octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-1303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.6 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.98 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Yellowish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-1303-1	1 in 1 BOX	12/19/2017
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/19/2017	09/30/2019

Labeler - General Bio Co., Ltd. (688299527)

Revised: 10/2019

Document Id: 96261301-e758-3992-e053-2a95a90a1f54

34390-5

Set id: 93d56658-ad4f-4f9a-af63-5662cebfe081

Version: 3

Effective Time: 20191030