FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR SA
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:39

Label at a glance#

ProductLBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N
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 6.00%

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 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, CYCLOHEXASILOXANE, ISODODECANE, GLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ALCOHOL DENAT., NYLON-12, NIACINAMIDE, HYDROXYETHYL UREA, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE, SODIUM PCA, POLYMETHYLSILSESQUIOXANE, ALBIZIA JULIBRISSIN BARK EXTRACT, SILICA, POLYSILICONE-11, PHENOXYETHANOL, CYCLOPENTASILOXANE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHERYL ACETATE, HEXYL LAURATE, SILICA DIMETHYL SILYLATE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, SILANEDIOL SALICYLATE, FRAGRANCE, RETINYL PALMITATE, ALCOHOL, TROMETHAMINE, ACACIA SENEGAL GUM EXTRACT, PANTHENOL, PROPANEDIOL, CERAMIDE NP, LECITHIN, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, HYDROLYZED SOY PROTEIN, POTASSIUM SORBATE, SODIUM BENZOATE, LAURETH-12, RICE AMINO ACIDS, PROLINE, ALGIN, HYALURONIC ACID, SODIUM HYALURONATE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, CALCIUM CITRATE, ETHYLHEXYLGLYCERIN.

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 LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Label BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Label ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Label CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-326-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N1 in 1 BOXEMULSION13
14141-326-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N26 mL in 1 BOTTLE, GLASSEMULSION263
14141-327-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 LATTE 180-F26 mL in 1 BOTTLE, GLASSEMULSION263
14141-327-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 LATTE 180-F1 in 1 BOXEMULSION13
14141-328-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 BEIGE 220-C1 in 1 BOXEMULSION13
14141-328-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 BEIGE 220-C26 mL in 1 BOTTLE, GLASSEMULSION263
14141-329-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 ALMENDRA 230-N26 mL in 1 BOTTLE, GLASSEMULSION263
14141-329-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 ALMENDRA 230-N1 in 1 BOXEMULSION13
14141-330-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CAPUCCINO 310-C26 mL in 1 BOTTLE, GLASSEMULSION263
14141-330-01LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CAPUCCINO 310-C1 in 1 BOXEMULSION13

Products#

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

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-32614141-326-01
14141-32914141-329-01
14141-32714141-327-01
14141-32814141-328-01
14141-33014141-330-01

Ingredients#

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

DailyMed ingredient rows page 1 of 8 · 285 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ISODODECANEA8289P68Y2IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
ALCOHOL3K9958V90MIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
CHLORPHENESINI670DAL4SZIACT
NYLON-12446U8J075BIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
MALTODEXTRIN7CVR7L4A2DIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
PEG-10 DIMETHICONE (220 CST)287GF3Y3WCIACT
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATEX2PZH4Y6HTIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SILANEDIOL SALICYLATEC054DF30K0IACT
TROMETHAMINE023C2WHX2VIACT
CERAMIDE NP4370DF050BIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROLINE9DLQ4CIU6VIACT
CALCIUM CITRATEMLM29U2X85IACT
LAURETH-12OAH19558U1IACT

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 CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf9266687-73d2-dac9-e053-6394a90ac2a12025-06-20WarningsExact identifier
ndc (package): 14141-330-01
ndc (package): 14141-327-01
ndc (package): 14141-326-01
ndc (package): 14141-329-01
ndc (package): 14141-328-01
ndc (product): 14141-327
ndc (product): 14141-328
ndc (product): 14141-330
ndc (product): 14141-329
ndc (product): 14141-326
ndc11 (package): 14141032901
ndc11 (package): 14141032601
ndc11 (package): 14141032801
ndc11 (package): 14141032701
ndc11 (package): 14141033001
spl id: 380515ad-828b-9707-e063-6394a90a5479
spl set id: f9266687-73d2-dac9-e053-6394a90ac2a1

Reported adverse events (FAERS/openFDA)#

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