FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR S A
Effective date
2024-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:33

Label at a glance#

ProductLBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C
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 Childrend under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.00%

Zinc oxide 2.94%

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
  • Childrend 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

Water, dimethicone, isododecane, glycerin, polymethylsilsesquioxane, polymethylsilsesquioxane/trimethylsiloxysilicate, saccharide isomerate, hdi/trimethylol hexyllactone crosspolymer, hydroxyethyl urea, peg/ppg-18/18 dimethicone, peg-10 dimethicone, zea mays (corn) starch (zea mays starch), polysilicone-11, silica, sodium pca, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, sorbitan sesquioleate, triethoxycaprylylsilane, caprylyl glycol, erythritol, chlorphenesin, disteardimonium hectorite, fragrance (parfum), niacinamide, tocopheryl acetate, peg-8 caprylic/capric glycerides, octyldodeceth-25, sodium hyaluronate, homarine hcl, propylene glycol, decylene glycol.

May Contain: Titanium dioxide, iron oxides.

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

Packaging - LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Packaging - BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Packaging - ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Packaging - CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Packaging - CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-310-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F27 mL in 1 TUBEEMULSION272
14141-310-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F1 in 1 BOXEMULSION12
14141-311-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C27 mL in 1 TUBEEMULSION272
14141-311-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C1 in 1 BOXEMULSION12
14141-312-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N27 mL in 1 TUBEEMULSION272
14141-312-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N1 in 1 BOXEMULSION12
14141-313-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C27 mL in 1 TUBEEMULSION272
14141-313-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C1 in 1 BOXEMULSION12
14141-314-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N27 mL in 1 TUBEEMULSION272
14141-314-01LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N1 in 1 BOXEMULSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-310LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S A]2Current NDC, Legacy NDC, 2 package rows20240403_ea3a0e07-a277-48c8-e053-2a95a90a172f.zip
14141-311LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S A]2Current NDC, Legacy NDC, 2 package rows20240403_ea3a0e07-a277-48c8-e053-2a95a90a172f.zip
14141-312LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S A]2Current NDC, Legacy NDC, 2 package rows20240403_ea3a0e07-a277-48c8-e053-2a95a90a172f.zip
14141-313LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S A]2Current NDC, Legacy NDC, 2 package rows20240403_ea3a0e07-a277-48c8-e053-2a95a90a172f.zip
14141-314LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) EMULSION LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) EMULSION [BEL STAR S A]2Current NDC, Legacy NDC, 2 package rows20240403_ea3a0e07-a277-48c8-e053-2a95a90a172f.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-31314141-313-01
14141-31114141-311-01
14141-31214141-312-01
14141-31014141-310-01
14141-31414141-314-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 180 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CHLORPHENESINI670DAL4SZIACT
OCTYLDODECETH-25F8934HEL3MIACT
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
SACCHARIDE ISOMERATEW8K377W98IIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
HOMARINE HYDROCHLORIDE8866LNG61NIACT
DECYLENE GLYCOLS57M60MI88IACT
ISODODECANEA8289P68Y2IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES00BT03FSO2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FERRIC OXIDE RED1K09F3G675IACT
HYALURONATE SODIUMYSE9PPT4THIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ERYTHRITOLRA96B954X6IACT
NIACINAMIDE25X51I8RD4IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
WATER059QF0KO0RIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
WATER059QF0KO0RIACT
STARCH, CORNO8232NY3SJIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT

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 HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBEL STAR S Aea3a0e07-a277-48c8-e053-2a95a90a172f2024-04-02WarningsExact identifier
ndc (package): 14141-312-01
ndc (package): 14141-314-01
ndc (package): 14141-310-01
ndc (package): 14141-311-01
ndc (package): 14141-313-01
ndc (product): 14141-314
ndc (product): 14141-311
ndc (product): 14141-313
ndc (product): 14141-312
ndc (product): 14141-310
ndc11 (package): 14141031001
ndc11 (package): 14141031301
ndc11 (package): 14141031401
ndc11 (package): 14141031101
ndc11 (package): 14141031201
spl id: 152028bd-044a-720a-e063-6294a90a1465
spl set id: ea3a0e07-a277-48c8-e053-2a95a90a172f

Reported adverse events (FAERS/openFDA)#

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