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 239 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
application number: M020
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
application number: M020
Pop Zinc SunscreenZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd2b29ddb2-5730-8a67-e063-6394a90ae4162025-01-07WarningsExact identifier
application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLCbbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c22025-01-07WarningsExact identifier
application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
application number: M020
Dimples Bath Co - Sunstick New Kid On The BlockZINC OXIDEDimples Bath Co. LLC26f682f4-2440-f111-e063-6294a90ab4b72025-01-06WarningsExact identifier
application number: M020
Diaper Rash Cream Happy CheeksDIAPER RASH HAPPY CHEEKSDimples Bath Co. LLC26cef2eb-a133-11ec-e063-6394a90a0f082025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26f85758-820f-3f73-e063-6294a90a289d2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Face MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0f0b56-233f-4c6a-e063-6394a90aea6f2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Body MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0fe721-b92a-4181-e063-6394a90a846a2025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact 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