PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (LIGHT)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (BLUSH MEDIUM)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (GOLDEN MEDIUM)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (LIGHT TAN)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (TAN)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (MEDIUM DARK)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (GOLDEN DARK)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (DEEP)- octinoxate liquid PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (DEEPER)- octinoxate liquid

Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEPER) by

Drug Labeling and Warnings

Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEPER) by is a Otc medication manufactured, distributed, or labeled by Purminerals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Medicinal Ingredient/Active Ingredient

Octinoxate 5.0 % w/w

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

• Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

• When using this product, keep out of eyes. Rinse with water to remove

• Keep out of reach of children. If swallowed, get medical help or contact a poison control center 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

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.

Non-Medicinal Ingredients/ Inactive Ingredients

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Amodimethicone, Aqua, Bambusa Vulgaris Leaf/Stem Extract, Bis-PEG/PPG-14/14 Dimethicone, Boron Nitride, Butyrospermum Parkii (Shea Butter) Extract, C12-C15 Alkyl Ethylhexanoate, Ceramide AP, Cetyl PEG/PPG-10/1 Dimethicone, Citric Acid, Cyclopentasiloxane, Dextrin, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disteardimonium Hectorite, EDTA, Ethylhexylglycerin, Ferulic Acid, Glucosamine HCL, Hydroxyethylcellulose, Lactic Acid, Laureth-7, Lecithin, Magnesium Sulfate, Mannitol, Pentylene Glycol, Phenoxyethanol, Pisum Sativum (Pea) Extract, Propanediol, Propylene Carbonate, Retinol, Silica Silylate, Sodium Citrate, Sodium Gluconate, Sodium PCA, Sodium Starch Octenylsuccinate, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane, Trihydroxystearin, Trimethylsiloxysilicate, Waltheria Indica Leaf Extract, Xanthan Gum, Zinc Stearate. May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Titanium Dioxide (CI 77891)

Other

Protect this product from excessive heat and direct sun

• In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

SPL UNCLASSIFIED SECTION

Distributed by pürminerals®
Atlanta, GA 30327

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Light

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Blush Medium

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden Medium

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Light Tan

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Tan

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Medium Dark

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden Dark

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Deep

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Deeper

pür™

4-in-1 Liquid

14-Hour Wear Foundation
Broad Spectrum SPF 15

1FL OZ/30ML

INGREDIENTS AND APPEARANCE

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (LIGHT) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0005-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (BLUSH MEDIUM) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0006-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (GOLDEN MEDIUM) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0007-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (LIGHT TAN) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0008-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (TAN) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0009-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (MEDIUM DARK) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0010-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (GOLDEN DARK) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0011-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (DEEP) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0012-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

PURMINERALS 4-IN-1 14-HOUR WEAR FOUNDATION BROAD SPECTRUM SPF 15 (DEEPER) 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67345-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ZINC STEARATE (UNII: H92E6QA4FV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
LAURETH-7 (UNII: Z95S6G8201)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SHEANUT OIL (UNII: O88E196QRF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEA (UNII: W4X7H8GYFM)
XANTHAN GUM (UNII: TTV12P4NEE)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ICODEXTRIN (UNII: 2NX48Z0A9G)
RETINOL (UNII: G2SH0XKK91)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
FERULIC ACID (UNII: AVM951ZWST)
EDETIC ACID (UNII: 9G34HU7RV0)
CERAMIDE AP (UNII: F1X8L2B00J)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67345-0013-0	1 in 1 CARTON	08/01/2012
1		30 mL in 1 BOTTLE, PUMP; 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	08/01/2012

Labeler - Purminerals (114450443)