BB FAIR- avobenzone, homosalate, octisalate, and octocrylene cream, augmented 
BB LIGHT- avobenzone, homosalate, octisalate, and octocrylene cream, augmented 
BB MEDIUM- avobenzone, homosalate, octisalate, and octocrylene cream, augmented 
BB DARK- avobenzone, homosalate, octisalate, and octocrylene cream, augmented 
SAYB International

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.

----------

BB Cream

Drug Facts

Active Ingredients

Avobenzone, 3.0%,
Homosalate, 2.5%,
Octisalate, 5.0%,
Octocrylene, 2.7%

Purpose

Sunscreen

Use

Warnings

  • Do not use on damaged or broken skin.

  • Keep out of eyes. Stop use if irritation occurs.

  • Keep out of reach of children. If swallowed, get medical help right away.

Directions

Other Information

Inactive Ingredients

Water, Diethylhexyl Carbonate, Ricinus Communis (Castor) Seed Oil, Glycerin,Ethyl Macadamiate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hydrogenated Castor Oil, Isododecane, Microcrystalline Wax, Neopentyl Glycol Diheptanoate, Hibiscus Abelmoschus Extract, Squalane, Palmitoyl Tripeptide-38, Tocopheryl Acetate, Magnesium Sulfate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glyceryl Dibehenate, Tribehenin, Sodium Chloride, Hydroxypropyl Cyclodextrin, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Behenate, Phenylethyl Resorcinol, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin. May Contain (+/-): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) <21101>

Dist. by SAYB International
CA, 90401 USA

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - FAIR

BB CREAM

BROAD SPECTRUM
SPF 25

NET WT.
1 FL. OZ./30 ML e

Principal Display Panel - 30 mL Tube Carton - FAIR

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - LIGHT

BB CREAM

BROAD SPECTRUM
SPF 25

NET WT.
1 FL. OZ./30 ML e

Principal Display Panel - 30 mL Tube Carton - LIGHT

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - MEDIUM

BB CREAM

BROAD SPECTRUM
SPF 25

NET WT.
1 FL. OZ./30 ML e

Principal Display Panel - 30 mL Tube Carton - MEDIUM

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK

BB CREAM

BROAD SPECTRUM
SPF 25

NET WT.
1 FL. OZ./30 ML e

Principal Display Panel - 30 mL Tube Carton - DARK
BB FAIR 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56001-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diethylhexyl Carbonate (UNII: YCD50O0Z6L)  
Castor Oil (UNII: D5340Y2I9G)  
Glycerin (UNII: PDC6A3C0OX)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Isododecane (UNII: A8289P68Y2)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
Abelmoschus Moschatus Seed (UNII: UN2QZ55I88)  
Squalane (UNII: GW89575KF9)  
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Magnesium Sulfate (UNII: DE08037SAB)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Glyceryl Dibehenate (UNII: R8WTH25YS2)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydroxypropyl .Beta.-Cyclodextrin (UNII: 1I96OHX6EK)  
Sunflower Oil (UNII: 3W1JG795YI)  
Phenylethyl Resorcinol (UNII: G37UFG162O)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorYELLOW (SKIN COLOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56001-400-301 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/15/2013
BB LIGHT 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56001-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diethylhexyl Carbonate (UNII: YCD50O0Z6L)  
Castor Oil (UNII: D5340Y2I9G)  
Glycerin (UNII: PDC6A3C0OX)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Isododecane (UNII: A8289P68Y2)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
Abelmoschus Moschatus Seed (UNII: UN2QZ55I88)  
Squalane (UNII: GW89575KF9)  
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Magnesium Sulfate (UNII: DE08037SAB)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Glyceryl Dibehenate (UNII: R8WTH25YS2)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydroxypropyl .Beta.-Cyclodextrin (UNII: 1I96OHX6EK)  
Sunflower Oil (UNII: 3W1JG795YI)  
Phenylethyl Resorcinol (UNII: G37UFG162O)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorYELLOW (SKIN COLOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56001-401-301 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/15/2013
BB MEDIUM 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56001-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diethylhexyl Carbonate (UNII: YCD50O0Z6L)  
Castor Oil (UNII: D5340Y2I9G)  
Glycerin (UNII: PDC6A3C0OX)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Isododecane (UNII: A8289P68Y2)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
Abelmoschus Moschatus Seed (UNII: UN2QZ55I88)  
Squalane (UNII: GW89575KF9)  
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Magnesium Sulfate (UNII: DE08037SAB)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Glyceryl Dibehenate (UNII: R8WTH25YS2)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydroxypropyl .Beta.-Cyclodextrin (UNII: 1I96OHX6EK)  
Sunflower Oil (UNII: 3W1JG795YI)  
Phenylethyl Resorcinol (UNII: G37UFG162O)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorYELLOW (SKIN COLOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56001-402-301 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/15/2013
BB DARK 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56001-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diethylhexyl Carbonate (UNII: YCD50O0Z6L)  
Castor Oil (UNII: D5340Y2I9G)  
Glycerin (UNII: PDC6A3C0OX)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
Isododecane (UNII: A8289P68Y2)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
Abelmoschus Moschatus Seed (UNII: UN2QZ55I88)  
Squalane (UNII: GW89575KF9)  
Palmitoyl Lysyldioxymethionyllysine (UNII: T7A529FB8O)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Magnesium Sulfate (UNII: DE08037SAB)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Glyceryl Dibehenate (UNII: R8WTH25YS2)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydroxypropyl .Beta.-Cyclodextrin (UNII: 1I96OHX6EK)  
Sunflower Oil (UNII: 3W1JG795YI)  
Phenylethyl Resorcinol (UNII: G37UFG162O)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorYELLOW (SKIN COLOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56001-403-301 in 1 CARTON
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/15/2013
Labeler - SAYB International (958886942)

Revised: 10/2015
Document Id: aedb4c21-62f0-4256-afaf-28bce61df64c
Set id: 7475ddf3-b575-489f-8226-fe26291153c1
Version: 1
Effective Time: 20151029
 
SAYB International