YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 1- octinoxate liquid YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 4- octinoxate liquid YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 7- octinoxate liquid YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 5- octinoxate liquid YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 3- octinoxate liquid YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2- octinoxate liquid

YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2 by

Drug Labeling and Warnings

YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2 by is a Otc medication manufactured, distributed, or labeled by Yanbal USA, Inc., Yanbal de Colombia S.A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 3%

Purpose: Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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
• 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 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-sleeve shirts, pants, hats and sunglasses
• 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

AQUA/WATER, CYCLOPENTASILOXANE, BIS-PEG/PPG-14/14 DIMETHICONE, TRIETHYLHEXANOIN, DIMETHICONE, BUTYLENE GLYCOL, C10-30 CHOLESTEROL/LANOSTEROL ESTERS, GLYCERIN, ISOHEXADECANE, SODIUM CHLORIDE, TALC, C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, PARFUM/FRAGRANCE, NYLON 12, DISTEARDIMONIUM HECTORITE, POLYPROPYLSILSESQUIOXANE, XANTHAN GUM, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, PROPYLENE CARBONATE, DISODIUM EDTA, MAGNESIUM SULFATE, MICA, CHLORPHENESIN, MYRICA PUBESCENS FRUIT WAX, C26-28 ALKYL DIMETHICONE, ALPINIA GALANGA LEAF EXTRACT, SODIUM HYALURONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491/CI 77492/CI 77499).

Company information

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

Product Packaging - Tono 1

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 2

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 3

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 4

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 5

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 7

YANBAL

BASE LÍQUIDA HIDRATANTE

MOISTURIZING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

INGREDIENTS AND APPEARANCE

YANBAL BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 1 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0001-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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 BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 4 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0004-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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 BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 7 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
FERROUS OXIDE (UNII: G7036X8B5H)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0006-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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 BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 5 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
FERROUS OXIDE (UNII: G7036X8B5H)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0005-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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 BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 3 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0003-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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 BASE LIQUIDA HIDRATANTE MOISTURIZING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23319-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STANNIC OXIDE (UNII: KM7N50LOS6)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
NYLON-12 (UNII: 446U8J075B)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
MICA (UNII: V8A1AW0880)
CHLORPHENESIN (UNII: I670DAL4SZ)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23319-0002-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; 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(23319-0001, 23319-0002, 23319-0003, 23319-0004, 23319-0005, 23319-0006)