FDA.reportPublic FDA data

YANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR LIPSTICK SUNSCREEN SPF 15

Manufacturer
Yanbal USA, Inc. | Yanbal de Colombia S.A.S.
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:05:34

Label at a glance#

ProductYANBAL HYDRA-LIP LABIAL COLOR INTENSO INTENSE COLOR SUNSCREEN SPF 15 ESTRELLA ROSA
Active ingredientOCTINOXATE
Label structure25 sections

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4%

Purpose: Sunscreen

Use

OTC - PURPOSE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

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.

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

INSTRUCTIONS FOR USE SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

ISOSTEARYL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, BIS-PEG-12 DIMETHICONE BEESWAX, CANDELILLA CERA / EUPHORBIA CERIFERA (CANDELILLA) WAX, POLYETHYLENE, BUTYLOCTYL SALICYLATE, HYDROGENATED POLYISOBUTENE, C10-30 CHOLESTEROL / LANOSTEROL ESTERS, HYDROGENATED POLYDECENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, AQUA / WATER, POLYGLYCERYL-10 HEPTAHYDROXYSTEARATE, CERA MICROCRISTALLINA / MICROCRYSTALLINE WAX, CETYL ALCOHOL, POLYAMIDE-5, CAPRYLYL GLYCOL, TOCOPHEROL, PARFUM / FRAGRANCE, PHENOXYETHANOL, OLIVE GLYCERIDES, ISOCETYL STEAROYL STEARATE, HEXYLENE GLYCOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCERIN, MYRICA PUBESCENS FRUIT WAX, HEXYL CINNAMIC ALDEHYDE, BENZYL SALICYLATE, LINALOOL, CITRONELLOL, HYDROXYCITRONELLAL, GERANIOL, CERAMIDE-3, BENZYL BENZOATE, LIMONENE, BENZYL CINNAMATE, BHT, ALPHA-ISOMETHYL IONONE, SYNTHETIC FLUORPHLOGOPITE, TIN OXIDE, SILICA, MICA, TITANIUM DIOXIDE (CI 77891), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 30 LAKE (CI 73360), IRON OXIDES (CI 77491), RED 7 LAKE (CI 15850), YELLOW 5 LAKE (CI 19140), RED 33 LAKE (CI 17200), MANGANESE VIOLET (CI 77742), YELLOW 10 LAKE (CI 47005), IRON OXIDES (CI 77499), IRON OXIDES (CI 77492), BLUE 1 LAKE (CI 42090), BRONZE POWDER (CI 77400), CARMINE (CI 75470), BISMUTH OXYCHLORIDE (CI 77163), RED 40 LAKE (CI 16035).

Company Information

SPL UNCLASSIFIED SECTION

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

Product Packaging - Ambre

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

ambreambre

Product Packaging - Chocolat

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

chocolatchocolat

Product Packaging - Creme Nude

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

creme nudecreme nude

Product Packaging - Guinda Etnico

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

guinda etnicoguinda etnico

Product Packaging - Lady Malbec

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

lady malbeclady malbec

Product Packaging - Orquidea Pink

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

orquidea pinkorquidea pink

Product Packaging - Rosa Toscana

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

rosa toscanarosa toscana

Product Packaging - Terciopelo Negro

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

terciopelo negroterciopelo negro

Product Packaging - Tierra de Rosas

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

tierra de rosastierra de rosas

Product Packaging - Berry Wine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

berry wineberry wine

Product Packaging - Classic Red

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

classic redclassic red

Product Packaging - Tentacion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

tentaciontentacion

Product Packaging - Ultra Red

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

ultra redultra red

Product Packaging - Estrella Rosa

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

estrella rosaestrella rosa

Product Packaging - Destello Rojo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

destello rojodestello rojo

Product Packaging - Zen on Fire

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

zen on firezen on fire

Product Packaging - Vibrant Ross

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

vibrant rossvibrant ross

Product Packaging - Sol de Arena

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

YANBAL

HYDRA-LIP LABIAL COLOR INTENSO

INTENSE COLOR LIPSTICK

SUNSCREEN SPF 15

Net wt. 4 g 0.14 oz

sol de arenasol de arena

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 71 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23319-002123319-0021-1
23319-002223319-0022-1
23319-002323319-0023-1
23319-002423319-0024-1
23319-002523319-0025-1
23319-002623319-0026-1
23319-002723319-0027-1
23319-002823319-0028-1
23319-002923319-0029-1
23319-003023319-0030-1
23319-003123319-0031-1
23319-003223319-0032-1
23319-003523319-0035-1
23319-004823319-0048-1
23319-005023319-0050-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 20 · 781 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C RED NO. 339DBA0SBB0LIACT
MANGANESE VIOLET72M48QQV8QIACT
CARMINIC ACIDCID8Z8N95NIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
BENZYL BENZOATEN863NB338GIACT
BENZYL CINNAMATEV67O3RO97UIACT
GERANIOLL837108USYIACT
LIMONENE, (+)-GFD7C86Q1WIACT
D&C RED NO. 272LRS185U6KIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 302S42T2808BIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
COPPER789U1901C5IACT
FD&C RED NO. 40WZB9127XOAIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CASTOR OILD5340Y2I9GIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
MICAV8A1AW0880IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
GLYCERINPDC6A3C0OXIACT
MORELLA PUBESCENS FRUIT WAX2N43GS24LVIACT
D&C RED NO. 6481744AI4OIACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
LINALOOL, (+/-)-D81QY6I88EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4f1775b-5df5-4b67-e053-2a95a90a2b6778eb9610-a67d-ad72-e053-2991aa0ad1da2020-11-25WarningsExact identifier
spl id: b4f1775b-5df5-4b67-e053-2a95a90a2b67
spl set id: 78eb9610-a67d-ad72-e053-2991aa0ad1da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.