FDA.reportPublic FDA data

NDC 83108-001-25 - The Tinted Serum Broad Spectrum SPF 50

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83108-001
Requested NDC
83108-001-25
Package NDCs from labels
83108-001-00, 83108-001-03, 83108-001-05, 83108-001-13, 83108-001-15, 83108-001-25
Manufacturer
Rationale Group Pty Ltd
Effective date
2025-12-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
The Tinted Serum Broad Spectrum SPF 50 - Rationale Group Pty LtdRationale Group Pty Ltd2025-12-03HUMAN OTC DRUG LABEL
Luminosity Activation Day Edition - Rationale Group Pty LtdRationale Group Pty Ltd2025-12-03HUMAN OTC DRUG LABEL
The Global Travel Kit - Rationale Group Pty LtdRationale Group Pty Ltd2024-08-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83108-001-00The Tinted Serum Broad Spectrum SPF 5030 mL in 1 BOTTLE, DROPPEREMULSION305
83108-001-00The Tinted Serum Broad Spectrum SPF 501 in 1 BOXEMULSION15
83108-001-03The Tinted Serum Broad Spectrum SPF 503 mL in 1 BOTTLE, DROPPEREMULSION35
83108-001-05The Tinted Serum Broad Spectrum SPF 505 mL in 1 BOTTLE, DROPPEREMULSION55
83108-001-13The Tinted Serum Broad Spectrum SPF 503 mL in 1 BOTTLEEMULSION35
83108-001-15The Tinted Serum Broad Spectrum SPF 505 mL in 1 BOTTLEEMULSION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83108-001THE TINTED SERUM BROAD SPECTRUM SPF 50 (ZINC OXIDE) EMULSION [RATIONALE GROUP PTY LTD]4Legacy NDC, 6 package rows20231102_f8ffcbc0-0dd3-4fce-b38b-37d38d631b61.zip
83108-001LUMINOSITY ACTIVATION DAY EDITION (ZINC OXIDE) KIT [RATIONALE GROUP PTY LTD]1Legacy NDC20231115_ba026282-38a6-4dd3-aa5a-fb6d215accc1.zip
83108-001THE GLOBAL TRAVEL KIT (ZINC OXIDE) KIT [RATIONALE GROUP PTY LTD]1Legacy NDC20240901_8a75b057-e38d-40db-b54f-8674e25a67a9.zip

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 386 · 7,711 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
unii: SOI2LOH54Z
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Zinc Cold Therapy Citrus FlavorZINC GLUCONATERARITAN PHARMACEUTICALS INCb859382d-9fa6-4cf1-b659-95b863f68d582026-09-08WarningsExact identifier
unii: U6WSN5SQ1Z
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
unii: SOI2LOH54Z
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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