FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
BEL STAR S.A.
Effective date
2026-09-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-25 02:01:07

Label at a glance#

ProductLBEL SOLUTIONS PRO-HIALURON BASE SERUM EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15...
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, phenoxyethanol, 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, 1,2-hexanediol, palmitoyl tetrapeptide-7, edta, sodium dna.

May Contain: titanium dioxide, iron oxides.

Product Packaging - CHAMPAGNE 170-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 14141-599-01

11

Product Packaging - LATTE 180-F

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14141-600-01

22

Product Packaging - BEIGE 220-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14141-601-01

33

Product Packaging - ALMENDRA 230-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14141-602-01

44

Product Packaging - CAPUCCINO 310-C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

14141-603-01

55

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/bf3rn4ALMENDRA 230N.jpg, CAPUCCINO 310C.jpg, BEIGE 220C.jpg, LATTE 180F.jpg, CHAMPAGNE 170N.jpg

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-60314141-603-01
14141-60114141-601-01
14141-60014141-600-01
14141-60214141-602-01
14141-59914141-599-01

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 215 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
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
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 98 · 1,953 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsName fallback
generic name: ZINC OXIDE
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsName fallback
generic name: ZINC OXIDE
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsName fallback
generic name: ZINC OXIDE
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsName fallback
generic name: ZINC OXIDE
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsName fallback
generic name: ZINC OXIDE

Reported adverse events (FAERS/openFDA)#

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