CareCella Hydration BB Cream

CareCella Hydration BB Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

CARECELLA HYDRATION BB CREAM- 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.

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CareCella Hydration BB Cream

Drug Facts

Active ingredients

Octinoxate 7.5%

Titanium Dioxide 4.2%

Zinc Oxide 7.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn. ● Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures ( see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply evenly 15 minutes before sun exposure.
  • Provides high protection against sunburn
  • 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.
  • Children under 6 months of age: Ask a doctor.

Inactive ingredients

Water, Cyclopentasiloxane, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Arbutin, Dimethicone, Talc, Caprylic/Capric Triglyceride, Sodium Chloride, Ferric Oxide Yellow, Yellow wax, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Ferric Oxide Red, PEG-10 Dimethicone Crosspolymer, Ozokerite, Fragrance, Ferrosoferric Oxide, Alcohol, Cyclotetrasiloxane, Adenosine, Soybean (Glycine Soja) Phytoplacenta Extract, Chamomile Flower Extract, Gentiana Lutea Root Extract, Wormwood Extract, Purslane Extract, Ginsenosides, Acer Saccharum Bark/Sap Extract

Other information

  • Protect the product in this container from excessive heat and direct sun.
  • You may also report serious side effects to this phone number

BROAD SPECTRUM SPF 50+

-FOR ALL SKIN TYPES-

High moisturization Line that recovers moisture and vitality of natural skin

Made in korea

Packaging

Hydration BB Cream

CARECELLA HYDRATION BB CREAM 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69422-1301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION42 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ARBUTIN (UNII: C5INA23HXF)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
CERESIN (UNII: Q1LS2UJO3A)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
ADENOSINE (UNII: K72T3FS567)  
SOYBEAN (UNII: L7HT8F1ZOD)  
CHAMOMILE (UNII: FGL3685T2X)  
GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
WORMWOOD (UNII: F84709P2XV)  
PURSLANE (UNII: M6S840WXG5)  
GINSENOSIDES (UNII: 3K198YD54P)  
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69422-1301-11 in 1 BOX12/15/2016
150 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 finalpart35212/15/201609/30/2019
Labeler - General Bio Co., Ltd. (688299527)

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