FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR S.A.
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:57

Label at a glance#

ProductLBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAG...
Active ingredientOCTINOXATE, ZINC OXIDE
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 4.90%

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

OTC - STOP USE SECTION

if 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

Isododecane, dimethicone, water, trimethylsiloxysilicate, butylene glycol, polyethylene, boron nitride, alcohol denat., silica, mica, peg/ppg-18/18 dimethicone, lecithin, peg-10 dimethicone, polysilicone-11, disteardimonium hectorite, phenoxyethanol, glycerin, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, propylene carbonate, fragrance, xanthan gum, propylene glycol, methylpropanediol, 4-terpineol, camellia sinensis leaf extract, salicylic acid, aesculus hippocastanum (horse chestnut) seed extract, hydrolyzed wheat protein, silybum marianum fruit extract, ‎salix alba ‎(‎willow‎) ‎bark ‎extract, potassium sorbate, sodium benzoate, polylysine, amyl salicylate, tetramethyl acetyloctahydronaphthalenes.

May Contain :

Titanium dioxide, iron oxides, barium sulfate.

Company Information

SPL UNCLASSIFIED SECTION

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

Made in Colombia. U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126. Made in Colombia.

www.lbel.com

Product Packaging ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-338-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N1 in 1 BOXEMULSION12
14141-338-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N27 g in 1 TUBEEMULSION272
14141-339-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C27 g in 1 TUBEEMULSION272
14141-339-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C1 in 1 BOXEMULSION12
14141-340-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C1 in 1 BOXEMULSION12
14141-340-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C27 g in 1 TUBEEMULSION272
14141-341-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N27 g in 1 TUBEEMULSION272
14141-341-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N1 in 1 BOXEMULSION12
14141-342-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F1 in 1 BOXEMULSION12
14141-342-01LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F27 g in 1 TUBEEMULSION272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-338LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, 2 package rows20240711_1bbf3712-b59d-cf6d-e063-6294a90af9b7.zip
14141-339LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, 2 package rows20240711_1bbf3712-b59d-cf6d-e063-6294a90af9b7.zip
14141-340LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, 2 package rows20240711_1bbf3712-b59d-cf6d-e063-6294a90af9b7.zip
14141-341LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, 2 package rows20240711_1bbf3712-b59d-cf6d-e063-6294a90af9b7.zip
14141-342LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S.A.]2Current NDC, 2 package rows20240711_1bbf3712-b59d-cf6d-e063-6294a90af9b7.zip

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-34114141-341-01
14141-34014141-340-01
14141-33914141-339-01
14141-34214141-342-01
14141-33814141-338-01

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 215 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CHLORPHENESINI670DAL4SZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BARIUM SULFATE25BB7EKE2EIACT
PROPYLENE CARBONATE8D08K3S51EIACT
AMYL SALICYLATEVZO9C30208IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MICAV8A1AW0880IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
ISODODECANEA8289P68Y2IACT
XANTHAN GUMTTV12P4NEEIACT
POLY-L-LYSINE (30000-70000 MW)0A1V8JTU2MIACT
FERRIC OXIDE RED1K09F3G675IACT
ALCOHOL3K9958V90MIACT
SALICYLIC ACIDO414PZ4LPZIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
4-TERPINEOL, (+)-HZK34LN80NIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SALIX ALBA BARK205MXS71H7IACT
HORSE CHESTNUT3C18L6RJAZIACT
BORON NITRIDE2U4T60A6YDIACT
WATER059QF0KO0RIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MILK THISTLEU946SH95EEIACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES2JU6ZH6GREIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
OCTINOXATE4Y5P7MUD51ACTIB

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 MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.1bbf3712-b59d-cf6d-e063-6294a90af9b72024-07-09WarningsExact identifier
ndc (package): 14141-339-01
ndc (package): 14141-338-01
ndc (package): 14141-342-01
ndc (package): 14141-341-01
ndc (package): 14141-340-01
ndc (product): 14141-339
ndc (product): 14141-340
ndc (product): 14141-338
ndc (product): 14141-342
ndc (product): 14141-341
ndc11 (package): 14141033801
ndc11 (package): 14141033901
ndc11 (package): 14141034001
ndc11 (package): 14141034201
ndc11 (package): 14141034101
spl id: 1cd9c047-d7fb-dc4e-e063-6394a90a6efa
spl set id: 1bbf3712-b59d-cf6d-e063-6294a90af9b7

Reported adverse events (FAERS/openFDA)#

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