FDA.reportPublic FDA data

SPF 101 Lightly Tinted

Manufacturer
The Acne Lab LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:35

Label at a glance#

ProductSPF 101 Lightly Tinted
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385415208150GTIN-13: 0385415208150
EAN-13: 0385415208150
GTIN-12: 385415208150
UPC-A: 385415208150
GTIN storage (14 digits): 00385415208150		Acne Lab SF 208.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85415-208-15SPF 101 Lightly Tinted15 g in 1 PACKETCREAM152

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
85415-20885415-208-15
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
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CERAMIDE 34370DF050BIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 774911K09F3G675IACT
CI 77492EX438O2MRTIACT
CI 77499XM0M87F357IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT

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
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
ndc (product): 85415-208
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
ndc (package): 85415-208-15
ndc (product): 85415-208
ndc11 (package): 85415020815
spl id: 4573f0fc-d57d-3f16-e063-6394a90ae433
spl set id: 334d694a-f9e4-ae86-e063-6394a90abfe1
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.