FDA.reportPublic FDA data

Lightly Tinted Mineral Block Sunscreen

Manufacturer
Tucson Acne Clinic | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:56

Label at a glance#

ProductLightly Tinted Mineral Block Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Warning:

INDICATIONS & USAGE SECTION

For external use only

Warning:

WARNINGS SECTION

For external use only

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

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 SAFETY INFORMATION

SAMPLE NOT FOR RESALE

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385301208158GTIN-13: 0385301208158
EAN-13: 0385301208158
GTIN-12: 385301208158
UPC-A: 385301208158
GTIN storage (14 digits): 00385301208158		Tucson Acne Clinic Lightly Tinted Mineral Block Sunscreen 208SF.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85301-208-15Lightly Tinted Mineral Block Sunscreen1.5 g in 1 PACKETCREAM1.52

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
85301-20885301-208-15
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
CI 77499XM0M87F357IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77492EX438O2MRTIACT
CI 774911K09F3G675IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CERAMIDE 34370DF050BIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONE92RU3N3Y1OIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT

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
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
ndc (package): 85301-208-15
ndc (product): 85301-208
ndc11 (package): 85301020815
spl id: 4586bfc8-b62a-0671-e063-6294a90a2087
spl set id: 30dfa973-3217-1e18-e063-6294a90a8d41
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
ndc (product): 85301-208
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.