NDC | 23319-0001-1, 23319-0002-1, 23319-0003-1, 23319-0004-1, 23319-0005-1, 23319-0006-1 |
Set ID | 77e6b4dd-ebdb-7963-e053-2991aa0a85f7 |
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
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).
Close - Company information
- 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 liquidProduct 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 liquidProduct 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 liquidProduct 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 liquidProduct 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 liquidProduct 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 liquidProduct 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)