NDC | 23319-0007-1, 23319-0008-1, 23319-0009-1, 23319-0010-1, 23319-0011-1, 23319-0012-1 |
Set ID | 77e6b501-8cb5-ffae-e053-2991aa0a24a9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Yanbal USA, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- 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.
Close - 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
WATER (AQUA), CYCLOPENTASILOXANE, ALCOHOL DENAT., ISONONYL ISONONANOATE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, KAOLIN, DIMETHICONE, DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIPENTAERYTHRITYL TETRABEHENATE/POLYHYDROXYSTEARATE, SODIUM CHLORIDE, FRAGRANCE (PARFUM), DIMETHICONE/PEG-10/15 CROSSPOLYMER, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, XANTHAN GUM, TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE, PROPYLENE CARBONATE, DISODIUM EDTA, CHLORPHENESIN, MYRICA PUBESCENS FRUIT WAX, RETINYL PALMITATE, ENANTIA CHLORANTHA BARK EXTRACT, OLEANOLIC ACID, MICA, IRON OXIDES (CI 77491/CI 77492/CI 77499), TITANIUM DIOXIDE (CI 77891).
Close - Company Information
- Product Packaging - Tono 1
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- Product Packaging - Tono 2
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- Product Packaging - Tono 3
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- Product Packaging - Tono 4
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- Product Packaging - Tono 5
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- Product Packaging - Tono 7
YANBAL
BASE LÍQUIDA MATIFICANTE
MATTIFYING LIQUID FOUNDATION
SUNSCREEN
BROAD SPECTRUM
SPF 15
27 ml 0.9 fl oz
- INGREDIENTS AND APPEARANCE
YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 1
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) FERROUS OXIDE (UNII: G7036X8B5H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0007-1 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 MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 3
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0009-1 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 MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 4
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0010-1 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 MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0008-1 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 MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 5
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0011-1 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 MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 7
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ALCOHOL (UNII: 3K9958V90M) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) WATER (UNII: 059QF0KO0R) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) CHLORPHENESIN (UNII: I670DAL4SZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROUS OXIDE (UNII: G7036X8B5H) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) KAOLIN (UNII: 24H4NWX5CO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23319-0012-1 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(23319-0007, 23319-0008, 23319-0009, 23319-0010, 23319-0011, 23319-0012)