FDA.reportPublic FDA data

Octinoxate, Zinc Oxide

Manufacturer
Bel Star S.A.
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:31:26

Label at a glance#

ProductLBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE ...
Active ingredientZINC OXIDE, OCTINOXATE
Label structure13 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.00%

Zinc oxide 4.20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE 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 help prevent sunburn, not skin cancer or early skin aging.
  • For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethicone, water, isododecane, peg-10 dimethicone, trimethylsiloxysilicate, glycerin, polymethylsilsesquioxane, propylene glycol, peg/ppg-18/18 dimethicone, hdi/trimethylol hexyllactone crosspolymer, polysilicone-11, dimethicone/vinyl dimethicone crosspolymer, sodium chloride, phenoxyethanol, silica, lecithin, silica dimethyl silylate, tocopheryl acetate, caprylyl glycol, triethoxycaprylylsilane, butylene glycol, chlorphenesin, disteardimonium hectorite, fragrance, kaolin, mica, camellia sinensis leaf extract, enantia chlorantha bark extract, aesculus hippocastanum (horse chestnut) seed extract, hydrolyzed wheat protein, silybum marianum fruit extract, potassium sorbate, sodium benzoate, oleanolic acid.

May Contain :

Titanium dioxide, iron oxides.

Company information

SPL UNCLASSIFIED SECTION

PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

USA: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

Made in Colombia.

www.lbel.com

LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-316-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F1 in 1 BOXEMULSION12
14141-316-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F27 mL in 1 TUBEEMULSION272
14141-317-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N1 in 1 BOXEMULSION12
14141-317-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N27 mL in 1 TUBEEMULSION272
14141-318-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N27 mL in 1 TUBEEMULSION272
14141-318-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N1 in 1 BOXEMULSION12
14141-319-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C27 mL in 1 TUBEEMULSION272
14141-319-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C1 in 1 BOXEMULSION12
14141-320-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C1 in 1 BOXEMULSION12
14141-320-01LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C27 mL in 1 TUBEEMULSION272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-316LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, Legacy NDC, 2 package rows20241030_eea17271-e8c8-ab21-e053-2995a90a2fcc.zip
14141-317LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, Legacy NDC, 2 package rows20241030_eea17271-e8c8-ab21-e053-2995a90a2fcc.zip
14141-318LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, Legacy NDC, 2 package rows20241030_eea17271-e8c8-ab21-e053-2995a90a2fcc.zip
14141-319LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, Legacy NDC, 2 package rows20241030_eea17271-e8c8-ab21-e053-2995a90a2fcc.zip
14141-320LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, Legacy NDC, 2 package rows20241030_eea17271-e8c8-ab21-e053-2995a90a2fcc.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-31614141-316-01
14141-31814141-318-01
14141-31914141-319-01
14141-32014141-320-01
14141-31714141-317-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 190 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MICAV8A1AW0880IACT
ANNICKIA CHLORANTHA BARKH70115MP4AIACT
MILK THISTLEU946SH95EEIACT
KAOLIN24H4NWX5COIACT
WATER059QF0KO0RIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
PEG-10 DIMETHICONE (220 CST)287GF3Y3WCIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHLORPHENESINI670DAL4SZIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB
OLEANOLIC ACID6SMK8R7TGJIACT
OCTINOXATE4Y5P7MUD51ACTIB
HORSE CHESTNUT3C18L6RJAZIACT
SODIUM CHLORIDE451W47IQ8XIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBel Star S.A.eea17271-e8c8-ab21-e053-2995a90a2fcc2024-10-28WarningsExact identifier
ndc (package): 14141-318-01
ndc (package): 14141-319-01
ndc (package): 14141-316-01
ndc (package): 14141-320-01
ndc (package): 14141-317-01
ndc (product): 14141-318
ndc (product): 14141-316
ndc (product): 14141-320
ndc (product): 14141-319
ndc (product): 14141-317
ndc11 (package): 14141031901
ndc11 (package): 14141031801
ndc11 (package): 14141031701
ndc11 (package): 14141032001
ndc11 (package): 14141031601
spl id: 258c982d-481d-03f7-e063-6394a90adf23
spl set id: eea17271-e8c8-ab21-e053-2995a90a2fcc

Reported adverse events (FAERS/openFDA)#

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