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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

Octinoxate 5.00% Zinc oxide 4.20%

Purpose

Sunscreen

Uses

Uses

Helps prevent sunburn.

Warnings

Warnings

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.

Directions And Dosage

Directions

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 Label Information

Inactive Ingredients

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.

LATTE 180-F

CHAMPAGNE 170-N

ALMENDRA 230-N

Label Images#

TONE LATTE 180-F
TONE LATTE 180-F
TONE CHAMPAGNE 170-N
TONE CHAMPAGNE 170-N
TONO - ALMENDRA 230-N
TONO - ALMENDRA 230-N
TONO - BEIGE 220-C
TONO - BEIGE 220-C
TONO CAPUCCINO 310-C
TONO CAPUCCINO 310-C

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#

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#

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

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

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.

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

CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML