DailyMed - 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

NDC Code(s): 67345-0005-0, 67345-0006-0, 67345-0007-0, 67345-0008-0, view more
67345-0009-0, 67345-0010-0, 67345-0011-0, 67345-0012-0, 67345-0013-0
Packager: Purminerals

Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 25, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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Official Label (Printer Friendly)

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	08/01/2012

Labeler - Purminerals (114450443)

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Published Date (What is this?)	Version	Files
Jan 30, 2023	3 (current)	download
Dec 27, 2019	2	download
May 9, 2014	1	download

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	NDC
1	67345-0005-0
2	67345-0006-0
3	67345-0007-0
4	67345-0008-0
5	67345-0009-0
6	67345-0010-0
7	67345-0011-0
8	67345-0012-0
9	67345-0013-0

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.