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 00:30:50

Label at a glance#

ProductLBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SP...
Active ingredientZINC OXIDE, OCTINOXATE
Label structure12 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 4.50%

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 hep 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

Dimethicone, water, isododecane, trimethylsiloxysilicate, peg-10 dimethicone, glycerin, polysilicone-11, peg/ppg-18/18 dimethicone, polymethylsilsesquioxane, hydroxyethyl urea, hdi/trimethylol hexyllactone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, sodium chloride, phenoxyethano, butylene glycol, silica, silica dimethyl silylate, triethoxycaprylylsilane, caprylyl glycol, disteardimonium hectorite, chlorphenesin, tocopheryl acetate, sucrose palmitate, glyceryl linoleate, carbomer, laureth-12, backhousia citriodora leaf extract, polysorbate 20, benzyl alcohol, citric acid, potassium sorbate, sodium hyaluronate, ethylhexylglycerin, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7.

May Contain: titanium dioxide, iron oxides.

Product Packaging - CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Packaging - CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-333-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N1 in 1 BOXLIQUID12
14141-333-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N30 mL in 1 BOTTLE, GLASSLIQUID302
14141-334-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F30 mL in 1 BOTTLE, GLASSLIQUID302
14141-334-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F1 in 1 BOXLIQUID12
14141-335-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C30 mL in 1 BOTTLE, GLASSLIQUID302
14141-335-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C1 in 1 BOXLIQUID12
14141-336-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N30 mL in 1 BOTTLE, GLASSLIQUID302
14141-336-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N1 in 1 BOXLIQUID12
14141-337-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C1 in 1 BOXLIQUID12
14141-337-01LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14141-333LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) LIQUID [BEL STAR S.A.]2Current NDC, 2 package rows20241030_0b782198-58e7-5343-e063-6294a90a3713.zip
14141-334LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) LIQUID [BEL STAR S.A.]2Current NDC, 2 package rows20241030_0b782198-58e7-5343-e063-6294a90a3713.zip
14141-335LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) LIQUID [BEL STAR S.A.]2Current NDC, 2 package rows20241030_0b782198-58e7-5343-e063-6294a90a3713.zip
14141-336LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) LIQUID [BEL STAR S.A.]2Current NDC, 2 package rows20241030_0b782198-58e7-5343-e063-6294a90a3713.zip
14141-337LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N (OCTINOXATE, ZINC OXIDE) LIQUID LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N (OCTINOXATE, ZINC OXIDE) LIQUID [BEL STAR S.A.]2Current NDC, 2 package rows20241030_0b782198-58e7-5343-e063-6294a90a3713.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-33714141-337-01
14141-33514141-335-01
14141-33414141-334-01
14141-33614141-336-01
14141-33314141-333-01

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 205 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
FERRIC OXIDE RED1K09F3G675IACT
LAURETH-12OAH19558U1IACT
BACKHOUSIA CITRIODORA LEAFFKN73KG747IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
POLYSORBATE 207T1F30V5YHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SUCROSE PALMITATE3OSQ643ZK5IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERYL LINOLEATE7B8K5VPO5SIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BENZYL ALCOHOLLKG8494WBHIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CHLORPHENESINI670DAL4SZIACT

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 EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.0b782198-58e7-5343-e063-6294a90a37132024-10-28WarningsExact identifier
ndc (package): 14141-336-01
ndc (package): 14141-335-01
ndc (package): 14141-334-01
ndc (package): 14141-337-01
ndc (package): 14141-333-01
ndc (product): 14141-337
ndc (product): 14141-336
ndc (product): 14141-335
ndc (product): 14141-333
ndc (product): 14141-334
ndc11 (package): 14141033401
ndc11 (package): 14141033501
ndc11 (package): 14141033601
ndc11 (package): 14141033301
ndc11 (package): 14141033701
spl id: 258ccaba-8161-8da2-e063-6394a90a7fe3
spl set id: 0b782198-58e7-5343-e063-6294a90a3713

Reported adverse events (FAERS/openFDA)#

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