FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR S.A.
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:19

Label at a glance#

ProductLBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170N
Active ingredientOCTINOXATE, ZINC OXIDE
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 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

Dimethicone, isododecane, water, mica, glycerin, trimethylsiloxysilicate, peg-10 dimethicone, hdi/trimethylol hexyllactone crosspolymer, alcohol denat., hydroxyethyl urea, peg/ppg-18/18 dimethicone, dimethicone/vinyl dimethicone crosspolymer, sodium pca, polysilicone-11, lecithin, phenoxyethanol, silica, sodium chloride, niacinamide, silica dimethyl silylate, triethoxycaprylylsilane, caprylyl glycol, disteardimonium hectorite, chlorphenesin, fragrance, panthenol, tocopheryl acetate, saccharomyces lysate, perfluorohexylethyl triethoxysilane, disodium succinate, glutamic acid, glycine, threonine, valine, amyl salicylate, tetramethyl acetyloctahydronaphthalenes. MAY CONTAIN : titanium dioxide, iron oxides.

Product Label CHAMPAGNE 170N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Label LATTE 180F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Label BEIGE 220C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

Product Label ALMENDRA 230N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Product Label CAPUCCINO 310C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-377-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170N1 in 1 BOXEMULSION12
14141-377-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170N26 mL in 1 BOTTLE, GLASSEMULSION262
14141-378-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 LATTE 180F26 mL in 1 BOTTLE, GLASSEMULSION262
14141-378-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 LATTE 180F1 in 1 BOXEMULSION12
14141-379-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 BEIGE 220C1 in 1 BOXEMULSION12
14141-379-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 BEIGE 220C26 mL in 1 BOTTLE, GLASSEMULSION262
14141-380-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 ALMENDRA 230N26 mL in 1 BOTTLE, GLASSEMULSION262
14141-380-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 ALMENDRA 230N1 in 1 BOXEMULSION12
14141-381-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CAPUCCINO 310C1 in 1 BOXEMULSION12
14141-381-01LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CAPUCCINO 310C26 mL in 1 BOTTLE, GLASSEMULSION262

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-37714141-377-01
14141-37814141-378-01
14141-37914141-379-01
14141-38014141-380-01
14141-38114141-381-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 185 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DISODIUM SUCCINATEV8ZGC8ISR3IACT
GLUTAMIC ACID3KX376GY7LIACT
VALINEHG18B9YRS7IACT
AMYL SALICYLATEVZO9C30208IACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES2JU6ZH6GREIACT
SODIUM PCA469OTG57A2IACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTINOXATE4Y5P7MUD51ACTIB
PEG-10 DIMETHICONE (220 CST)287GF3Y3WCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GLYCERINPDC6A3C0OXIACT
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
ISODODECANEA8289P68Y2IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
WATER059QF0KO0RIACT
GLYCINETE7660XO1CIACT
THREONINE2ZD004190SIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CHLORPHENESINI670DAL4SZIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
FERROUS OXIDEG7036X8B5HIACT
DIMETHICONE92RU3N3Y1OIACT
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ALCOHOL3K9958V90MIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DISODIUM SUCCINATEV8ZGC8ISR3IACT
GLUTAMIC ACID3KX376GY7LIACT

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-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.2f769ed5-0176-8c80-e063-6394a90a92c62025-08-21WarningsExact identifier
ndc (package): 14141-381-01
ndc (package): 14141-380-01
ndc (package): 14141-377-01
ndc (package): 14141-378-01
ndc (package): 14141-379-01
ndc (product): 14141-379
ndc (product): 14141-381
ndc (product): 14141-377
ndc (product): 14141-378
ndc (product): 14141-380
ndc11 (package): 14141037701
ndc11 (package): 14141037801
ndc11 (package): 14141038001
ndc11 (package): 14141038101
ndc11 (package): 14141037901
spl id: 3ce4ed3d-cdfd-74f4-e063-6294a90a06f0
spl set id: 2f769ed5-0176-8c80-e063-6394a90a92c6

Reported adverse events (FAERS/openFDA)#

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