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 291 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Golden Glow Tanning Oil SPF-15AVOBENZONE, OCTISALATE, OCTOCRYLENETANNING CLUB, LLC748a9933-02a3-48c1-8636-8f0468f66a132024-07-17WarningsExact identifier
application number: M020
Tan De Soleil Orange Tanning Balm SPF 6HOMOSALATE, OCTISALATETANNING CLUB, LLC5343f359-6074-467c-99bb-f08a7ca2df412024-07-17WarningsExact identifier
application number: M020
Tanning Club Tanning SPF-8AVOBENZONE, OCTOCRYLENETANNING CLUB, LLCbbf9d61e-f2e6-4fde-baad-c412091c60b62024-07-17WarningsExact identifier
application number: M020
Mackenzies SPF 40 Ocean Safe SunscreenZINC OXIDENaturally Uncommon LLC1c314b70-45a7-1bd1-e063-6294a90a0d6b2024-07-17WarningsExact identifier
application number: M020
Bitchstix Eucalyptus Mint SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d764eb8-a0a7-d034-e063-6394a90aef242024-07-17WarningsExact identifier
application number: M020
Bitchstix Acai Berry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d765c28-f9da-15b6-e063-6394a90a057f2024-07-17WarningsExact identifier
application number: M020
Bitchstix Banana Kiwi SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e972-4fc1-9438-e063-6294a90a58452024-07-17WarningsExact identifier
application number: M020
Bitchstix Pineapple Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7699f4-3088-9436-e063-6294a90ab8522024-07-17WarningsExact identifier
application number: M020
Bitchstix Black Cherry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76824a-eac4-2d1f-e063-6294a90a8e662024-07-17WarningsExact identifier
application number: M020
Bitchstix Classic Coconut SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76aed7-308b-5cc5-e063-6394a90a45432024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Watermelon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d76e9b7-95af-6015-e063-6294a90a6f192024-07-17WarningsExact identifier
application number: M020
Bitchstix Vanilla Creme SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7713a9-de97-f0ff-e063-6294a90a80032024-07-17WarningsExact identifier
application number: M020
Bitchstix Grapefruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d7723c7-984a-a789-e063-6394a90abdc42024-07-17WarningsExact identifier
application number: M020
Bitchstix Matcha and Aloe SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d771406-7c59-6052-e063-6394a90a01e62024-07-17WarningsExact identifier
application number: M020
Bitchstix Lemon Twist SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d770a10-a9fa-94c4-e063-6294a90a137a2024-07-17WarningsExact identifier
application number: M020
Bitchstix Mango SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77866e-64f2-86d6-e063-6394a90a12922024-07-17WarningsExact identifier
application number: M020
Bitchstix Peachy Peach SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77c31e-c606-74b7-e063-6294a90a2cee2024-07-17WarningsExact identifier
application number: M020
Bitchstix Pink Lemon SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77d785-56eb-e865-e063-6394a90acd012024-07-17WarningsExact identifier
application number: M020
Bitchstix Pomegranate SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffd-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix Strawberry Dragon Fruit SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77f460-e7be-30fe-e063-6394a90a8f1e2024-07-17WarningsExact 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