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

BB DARK by

Drug Labeling and Warnings

BB DARK by is a Otc medication manufactured, distributed, or labeled by SAYB International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Use

• Helps prevent sunburn

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

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor

Other Information

• Protect this product from excessive heat and direct sun

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>

SPL UNCLASSIFIED SECTION

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 - LIGHT

BB CREAM

BROAD SPECTRUM
SPF 25

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

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 - DARK

BB CREAM

BROAD SPECTRUM
SPF 25

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

INGREDIENTS AND APPEARANCE

BB FAIR 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56001-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (SKIN COLOR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56001-400-30	1 in 1 CARTON
1		30 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 FINAL	part352	03/15/2013

BB LIGHT 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56001-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (SKIN COLOR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56001-401-30	1 in 1 CARTON
1		30 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 FINAL	part352	03/15/2013

BB MEDIUM 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56001-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (SKIN COLOR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56001-402-30	1 in 1 CARTON
1		30 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 FINAL	part352	03/15/2013

BB DARK 
avobenzone, homosalate, octisalate, and octocrylene cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56001-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	25 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (SKIN COLOR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56001-403-30	1 in 1 CARTON
1		30 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 FINAL	part352	03/15/2013

Labeler - SAYB International (958886942)