FDA.reportPublic FDA data

PUR 4-in-1 Skin Tint TN7

Product NDC
67345-0055
11-digit product format
673450055
Labeler code
67345
Product ID
67345-0055_3f8eef2d-e0c5-631f-e063-6294a90ab2b5
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
PUR Minerals
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-19
Substance
ZINC OXIDE
Active strength
132 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PUR 4-in-1 Skin Tint TN7
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f0717c7-f43f-e3b1-e063-6394a90a74ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67345-0055-0PUR 4-in-1 Skin Tint TN71 in 1 CARTONLOTION12
67345-0055-1PUR 4-in-1 Skin Tint TN730 mL in 1 BOTTLELOTION302

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 223 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY311ae6d6-d466-3f1d-e063-6294a90ab3dd2025-03-24WarningsExact identifier
application number: M020
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311de9db-941c-5af9-e063-6294a90a3a132025-03-24WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacy311e6378-5afa-d7eb-e063-6394a90a77282025-03-24WarningsExact identifier
application number: M020
Naked Sundays Golden Glow Body Sunscreen SPF50 100mlNAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100MLNAKED SUNDAYS PTY LTDe182a39b-89b1-7756-e053-2a95a90ab6192025-03-23WarningsExact identifier
application number: M020
ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUMAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDeb7a84a8-3e25-9988-e053-2a95a90a58a92025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
application number: M020
GLOW BODY MIST SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDcba78484-3c0b-413e-e053-2995a90aad862025-03-23WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.2a86be75-c0f3-a8a1-e063-6294a90a04482025-03-23WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfc1e74-139e-8b0d-e053-6394a90a97c52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD2499e14a-c14f-ea13-e063-6394a90a62f52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24aa19c8-86d9-c691-e063-6394a90a691e2025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a98d3d-f830-9614-e063-6394a90aa7d12025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM CHAMPAGNE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfb871b-460f-271a-e053-6394a90acad22025-03-22WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8gZINC OXIDENAKED SUNDAYS PTY LTD2f42d22a-983e-d304-e063-6294a90a37192025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19gAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%NAKED SUNDAYS PTY LTD2f47a6c9-dd0a-da94-e063-6294a90a9a452025-03-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67345-0055-0673450055001 BOTTLE in 1 CARTON (67345-0055-0) / 30 mL in 1 BOTTLE (67345-0055-1) 1 bottle2025-06-19NoNoCurrent
67345-0055-16734500550130 mL in 1 BOTTLE30 mlHistorical