Tinted Lip Sunscreen

Product NDC
85331-212
11-digit product format
853310212
Labeler code
85331
Product ID
85331-212_34a5a99f-9e23-52ab-e063-6294a90a9323
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Scottsdale Skin Boutique and Dermatology Pllc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-20
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 40 mg/g; mg/g
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
Tinted Lip Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE38 mg/g
TITANIUM DIOXIDE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
34a5a99f-9e22-52ab-e063-6294a90a9323Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85331-212-45Tinted Lip Sunscreen4.5 g in 1 BOTTLE, PUMPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85331-212TINTED LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC]1Current NDC, 1 package rows20250510_34a5a99f-9e22-52ab-e063-6294a90a9323.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 21 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c09714-6137-7102-e063-6294a90a72a42026-06-08WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c13cc3-208e-ae7d-e063-6294a90a2a032026-06-08WarningsExact identifier
application number: M020
Innisfree Daily UV Defense Mineral SunscreenZINC OXIDE LOTIONInnisfree Corporation0e9cd3e5-cff8-7594-e063-6394a90aad902026-06-08WarningsExact identifier
application number: M020
Paulas Choice Lipscreen Broad Spectrum SPF 50OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENECosmetic Solutions LLC4c37e10c-3da5-4a48-b2c1-1b99ce9a02c12026-06-08WarningsExact identifier
application number: M020
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
application number: M020
Inflair Elevate SPF15 MoisturizerETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Yapheon Health Industry Co., Ltd53a724e9-229e-eea4-e063-6294a90a7d5e2026-06-07WarningsExact identifier
application number: M020
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
application number: M020
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC538429b8-4f0e-e825-e063-6294a90a59052026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC5384da3c-4017-a3c1-e063-6294a90ae9a32026-06-05WarningsExact identifier
application number: M020
MEDULTIMA ADVENTURE SUNSCREENHOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.5368b2b3-fd80-9659-e063-6394a90a0ad32026-06-04WarningsExact identifier
application number: M020
WEN SixThirteen SPF 20 Dry Oil Intensive TreatmentOCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONEWEN by Chaz Dean536e6291-f5ca-37a4-e063-6394a90adfdb2026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
application number: M020
Glow Gloss Lip Balm SPF 40 Vanilla Soft ServeHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATESupergoop!26d2897f-46a7-52b2-e063-6394a90aed322026-06-04WarningsExact identifier
application number: M020
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
application number: M020
Abib No White Cast SPF Gift SetHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.537420bb-9fd8-0649-e063-6394a90aa8cf2026-06-04WarningsExact identifier
application number: M020
Airy sunstick smooting barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.f8203d54-cd3d-314d-e053-6394a90ac10d2026-06-04WarningsExact identifier
application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85331-212-45853310212454.5 g in 1 BOTTLE, PUMP (85331-212-45) 4.5 g2022-07-20NoNoCurrent