FDA.reportPublic FDA data

Tinted Replenishing SPF40

Manufacturer
RSL89 LLC | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:22:41

Label at a glance#

ProductTinted Replenishing SPF40
Active ingredientZINC OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85508-208-15Tinted Replenishing SPF401.5 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
85508-20885508-208-15
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 CROSSPOLYMERUF7620L1W6IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
CI 77492EX438O2MRTIACT
CI 77499XM0M87F357IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ZINC OXIDESOI2LOH54ZACTIB
CERAMIDE 34370DF050BIACT
CI 774911K09F3G675IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT

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
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC353257db-6c30-4a03-e063-6294a90ae45d2025-12-12Exact identifier
ndc (product): 85508-208
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC35334c75-b3fd-37fa-e063-6294a90ab3b02025-12-12Exact identifier
ndc (package): 85508-208-15
ndc (product): 85508-208
ndc11 (package): 85508020815
spl id: 45c70c10-47dc-8885-e063-6294a90adf67
spl set id: 35334c75-b3fd-37fa-e063-6294a90ab3b0
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.