FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR SA
Effective date
2025-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:40

Label at a glance#

ProductLBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAM...
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 4.20%

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

Water, Dimethicone, Isododecane, Peg-10 Dimethicone, Trimethylsiloxysilicate, Propylene Glycol, Mica, Dimethicone/vinyl Dimethicone Crosspolymer, Peg/ppg-18/18 Dimethicone, Polysilicone-11, Glycerin, Lecithin, Sodium Chloride, Phenoxyethanol, Silica, Silica Dimethyl Silylate, Backhousia Citriodora Leaf Extract, Maltodextrin, Caprylyl Glycol, Disteardimonium Hectorite, Hydroxyethyl Urea, Peg-8 Caprylic/capric Glycerides, Chlorphenesin, Tocopheryl Acetate, Lactobacillus Ferment, Octyldodeceth-25, Perfluorohexylethyl Triethoxysilane, Sodium Hyaluronate, Decylene Glycol.

May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane.

Company Information

SPL UNCLASSIFIED SECTION

U.S.A. & PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926, Made in Colombia.

www.lbel.com

Package Label CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Label CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

Package Label LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

Package Label BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

Package Label ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-321-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-N1 in 1 BOXEMULSION13
14141-321-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-N30 mL in 1 BOTTLE, GLASSEMULSION303
14141-322-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CAPUCCINO 310-C1 in 1 BOXEMULSION13
14141-322-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CAPUCCINO 310-C30 mL in 1 BOTTLE, GLASSEMULSION303
14141-323-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 LATTE 180-F30 mL in 1 BOTTLE, GLASSEMULSION303
14141-323-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 LATTE 180-F1 in 1 BOXEMULSION13
14141-324-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 BEIGE 220-C1 in 1 BOXEMULSION13
14141-324-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 BEIGE 220-C30 mL in 1 BOTTLE, GLASSEMULSION303
14141-325-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 ALMENDRA 230-N30 mL in 1 BOTTLE, GLASSEMULSION303
14141-325-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 ALMENDRA 230-N1 in 1 BOXEMULSION13

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
14141-32114141-321-01
14141-32214141-322-01
14141-32314141-323-01
14141-32414141-324-01
14141-32514141-325-01

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
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BACKHOUSIA CITRIODORA LEAFFKN73KG747IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES00BT03FSO2IACT
PERFLUOROOCTYL TRIETHOXYSILANE814P46684UIACT
SODIUM CHLORIDE451W47IQ8XIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
CHLORPHENESINI670DAL4SZIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECETH-25F8934HEL3MIACT
MALTODEXTRIN7CVR7L4A2DIACT
DECYLENE GLYCOLS57M60MI88IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (220 CST)287GF3Y3WCIACT
ISODODECANEA8289P68Y2IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MICAV8A1AW0880IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT

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 SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf459c27e-e607-47ba-e053-2a95a90a901f2025-06-22WarningsExact identifier
ndc (package): 14141-322-01
ndc (package): 14141-324-01
ndc (package): 14141-321-01
ndc (package): 14141-323-01
ndc (package): 14141-325-01
ndc (product): 14141-323
ndc (product): 14141-325
ndc (product): 14141-322
ndc (product): 14141-324
ndc (product): 14141-321
ndc11 (package): 14141032201
ndc11 (package): 14141032401
ndc11 (package): 14141032501
ndc11 (package): 14141032101
ndc11 (package): 14141032301
spl id: 382fd12d-c4f9-d810-e063-6294a90af148
spl set id: f459c27e-e607-47ba-e053-2a95a90a901f

Reported adverse events (FAERS/openFDA)#

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