FDA.reportPublic FDA data

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 35 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THANKYOU FARMER Sun Project Soothing SunOCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATETHANK YOU FARMER CO., LTD300ab1bc-9c11-c2f0-e063-6394a90aa8532026-05-06WarningsExact identifier
application number: M020
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50ZINC OXIDE, OCTINOXATEPrivate Label Skin Care9eb7f287-cb61-4f9d-968e-16b195dbbc9a2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior53a79ee7-312b-49a2-8a9b-c50794fcd1712026-05-05WarningsExact identifier
application number: M020
SPF 50 Dry Tropix with fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp2c95f5c0-7ff6-4eac-b2d6-49e7da7e7bec2026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF30 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp9592835a-7c07-487e-a955-04fdea0708092026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp65f52fc8-8ddb-4282-9bc0-92a7d0e0c0f22026-05-05WarningsExact identifier
application number: M020
Knesko Skin The SunscreenZINC OXIDEKnesko, LLC5114dc75-a865-326e-e063-6294a90a89112026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp683cb489-e4e1-44ab-9543-614d42b08edd2026-05-05WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
application number: M020
Surface Sun SPF 50 Mineral SunscreenZINC OXIDE 24%Surface Products Corp6f95de43-cb71-4ddd-b438-a35ee2e14fae2026-05-05WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPort Jervis Laboratories, Inc5118a0a4-728b-6884-e063-6394a90a02b32026-05-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baed7205-2e0d-c6aa-e053-2995a90a8e292026-05-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baee366f-c1a0-5e21-e053-2a95a90a66872026-05-05WarningsExact identifier
application number: M020
Carmex Sun and Soothe Moisturizing Lip Balm SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.fc4d2387-ce6a-4105-bab4-7d371b61f7702026-05-05WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Soothing SunHOMOSALATE, OCTISALATE. AVOBENZONETHANK YOU FARMER CO., LTD3009df84-4ca7-e170-e063-6294a90a15782026-05-05WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Moisture SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONETHANK YOU FARMER CO., LTD300d8526-0daf-2255-e063-6394a90a21b12026-05-05WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Rice Tinted Mineral SunscreenZINC OXIDETHANK YOU FARMER CO., LTD30086b1e-d876-2528-e063-6294a90a4e9f2026-05-04WarningsExact identifier
application number: M020
Blue Berry SPF 15 Broad Spectrum Lip BalmBLUE BERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff6ecb-c8b3-02fc-e063-6394a90a68de2026-05-04WarningsExact 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