FDA.reportPublic FDA data

Mineral Sunscreen

Manufacturer
ISIS GONZALEZ | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:25:41

Label at a glance#

ProductMineral Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps Prevent Sunburn. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps Prevent Sunburn. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130387121208509GTIN-13: 0387121208509
EAN-13: 0387121208509
GTIN-12: 387121208509
UPC-A: 387121208509
GTIN storage (14 digits): 00387121208509		Bello 208.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87121-208-50Mineral Sunscreen50 g in 1 BOTTLE, PUMPCREAM502

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87121-20887121-208-50
58892-208

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
CERAMIDE 34370DF050BIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CI 774911K09F3G675IACT
CI 77499XM0M87F357IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONE92RU3N3Y1OIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CI 77492EX438O2MRTIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f68b2ea-be23-100d-e063-6294a90a8b372025-12-16WarningsExact identifier
ndc (product): 87121-208
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f682b78-e1c9-e174-e063-6294a90a17ed2025-12-16WarningsExact identifier
ndc (package): 87121-208-50
ndc (product): 87121-208
ndc11 (package): 87121020850
spl id: 4615180f-7368-8b5a-e063-6394a90af586
spl set id: 3f682b78-e1c9-e174-e063-6294a90a17ed
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
ndc (product): 58892-208

Reported adverse events (FAERS/openFDA)#

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