ERBORIAN BB CREME AU GINSENG CHOCOLATE SPF 20- octisalate, titanium dioxide, zinc oxide cream 
LABORATOIRES M&L

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.

----------

Erborian BB creme au Ginseng chocolate SPF 20

Drug Facts

Active ingredients

Octisalate 4%

Titanium dioxide 3.54%

Zinc oxide 2.94%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • 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

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • 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

Other information

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

Inactive ingredients

AQUA/WATER - DIMETHICONE - CI 77492/IRON OXIDES - CAPRYLIC/CAPRIC TRIGLYCERIDE - GLYCERIN - BUTYLOCTYL SALICYLATE - CI 77491/IRON OXIDES - HEXYL LAURATE - DISILOXANE - CI 77499/IRON OXIDES - PEG-10 DIMETHICONE - DISTEARDIMONIUM HECTORITE - BETAINE - BUTYLENE GLYCOL - PENTYLENE GLYCOL - MAGNESIUM SULFATE - CI 77891/TITANIUM DIOXIDE - PANAX GINSENG ROOT EXTRACT - GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT - KIGELIA AFRICANA FRUIT EXTRACT - DIOSCOREA VILLOSA (WILD YAM) ROOT EXTRACT - EQUISETUM GIGANTEUM EXTRACT - CETYL PEG/PPG-10/1 DIMETHICONE - DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER - TRIETHOXYCAPRYLYLSILANE - SYNTHETIC FLUORPHLOGOPITE - STEARIC ACID - ALUMINA - GLYCERYL CAPRYLATE - PALMITIC ACID - CAPRYLYL GLYCOL - ALUMINUM HYDROXIDE - PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE - TIN OXIDE - ALCOHOL - ETHYLHEXYLGLYCERIN - PARFUM/FRAGRANCE - HEXYL CINNAMAL - ALPHA-ISOMETHYL IONONE - LINALOOL - CITRONELLOL – GERANIOL

Questions or comments?

Call toll free 1-888-975-2162

Package Labeling:

Label

ERBORIAN BB CREME AU GINSENG CHOCOLATE SPF 20 
octisalate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10345-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
BETAINE (UNII: 3SCV180C9W)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10345-904-451 in 1 BOX05/01/2022
145 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 finalpart35205/01/2022
Labeler - LABORATOIRES M&L (262533623)

Revised: 4/2022
Document Id: ddcd6f25-2edc-4db5-e053-2a95a90a515d
Set id: ddcd6ea4-e7b1-88df-e053-2a95a90a9923
Version: 1
Effective Time: 20220429
 
LABORATOIRES M&L