YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5- titanium dioxide powder YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 6-7- titanium dioxide powder YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 1- titanium dioxide powder YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3- titanium dioxide powder

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3 by

Drug Labeling and Warnings

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3 by is a Otc medication manufactured, distributed, or labeled by Yanbal USA, Inc., Yanbal de Colombia S.A.S., Unique S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 8.7%

Purpose: Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating or immediately after towel drying
• children under 6 months: Ask a doctor.

Other information

• protect this product from excessive heat and direct sun
• report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

TALC, MICA, SYNTHETIC FLUORPHLOGOPITE, ALUMINUM CALCIUM SODIUM SILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIISOPROPYL DIMER DILINOLEATE, NYLON 12, ALUMINUM HYDROXIDE, MAGNESIUM MYRISTATE, ACRYLATE COPOLYMER, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, ETHYLHEXYL PALMITATE, DECYLENE GLYCOL, HYDRATED SILICA, MYRICA PUBESCENS FRUIT WAX, SILICA, LUFFA CYLINDRICA SEED OIL, TIN OXIDE, IRON OXIDES (CI 77491/CI 77492/ CI 77499), TITANIUM DIOXIDE (CI 77891) MANGANESE VIOLET (CI 77742), ULTRAMARINES (CI 77007).

Company information

Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

Product Packaging - Tono 1

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

Product Packaging - Tono 2-3

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

Procut Packaging - Tono 4-5

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

Product Packaging - Tono 6-7

YANBAL

POLVOS COMPACTOS

PRESSED POWDER

SUNSCREEN

SPF 12

Net wt. 6.5 g 0.22 oz

INGREDIENTS AND APPEARANCE

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	87 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
STANNIC OXIDE (UNII: KM7N50LOS6)
DECYLENE GLYCOL (UNII: S57M60MI88)
ULTRAMARINE BLUE (UNII: I39WR998BI)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
FERROUS OXIDE (UNII: G7036X8B5H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MICA (UNII: V8A1AW0880)
ALUMINUM OXIDE (UNII: LMI26O6933)
TALC (UNII: 7SEV7J4R1U)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
NYLON-12 (UNII: 446U8J075B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0015-1	1 in 1 CARTON	11/15/2018
1		6.5 g in 1 CONTAINER; 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	11/15/2018

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 6-7 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	87 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
STANNIC OXIDE (UNII: KM7N50LOS6)
DECYLENE GLYCOL (UNII: S57M60MI88)
ULTRAMARINE BLUE (UNII: I39WR998BI)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
FERROUS OXIDE (UNII: G7036X8B5H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MICA (UNII: V8A1AW0880)
ALUMINUM OXIDE (UNII: LMI26O6933)
TALC (UNII: 7SEV7J4R1U)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0016-1	1 in 1 CARTON	11/15/2018
1		6.5 g in 1 CONTAINER; 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	11/15/2018

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 1 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	87 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
STANNIC OXIDE (UNII: KM7N50LOS6)
DECYLENE GLYCOL (UNII: S57M60MI88)
ULTRAMARINE BLUE (UNII: I39WR998BI)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
FERROUS OXIDE (UNII: G7036X8B5H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MICA (UNII: V8A1AW0880)
ALUMINUM OXIDE (UNII: LMI26O6933)
TALC (UNII: 7SEV7J4R1U)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0013-1	1 in 1 CARTON	11/15/2018
1		6.5 g in 1 CONTAINER; 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	11/15/2018

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	87 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MANGANESE VIOLET (UNII: 72M48QQV8Q)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
STANNIC OXIDE (UNII: KM7N50LOS6)
DECYLENE GLYCOL (UNII: S57M60MI88)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
FERROUS OXIDE (UNII: G7036X8B5H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TALC (UNII: 7SEV7J4R1U)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0014-1	1 in 1 CARTON	11/15/2018
1		6.5 g in 1 CONTAINER; 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	11/15/2018

Labeler - Yanbal USA, Inc. (001801369)

Establishment
Name	Address	ID/FEI	Business Operations
Yanbal de Colombia S.A.S.		880215657	manufacture(23319-0013, 23319-0014, 23319-0015, 23319-0016)

Establishment
Name	Address	ID/FEI	Business Operations
Unique S.A.		934396326	manufacture(23319-0013, 23319-0014, 23319-0015, 23319-0016)