FDA.reportPublic FDA data

Mineral Lip Sunscreen Tinted

Product NDC
85634-212
11-digit product format
856340212
Labeler code
85634
Product ID
85634-212_45b433c3-b48f-e64e-e063-6394a90a8f45
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-11
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
55; 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
Mineral Lip Sunscreen Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE55 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
3728ec6a-7de5-bbc5-e063-6294a90a31b7Available 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
85634-212-45Mineral Lip Sunscreen Tinted1 in 1 CARTONSTICK12
85634-212-45Mineral Lip Sunscreen Tinted4.5 g in 1 CYLINDERSTICK4.52

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 132 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37644dfd-e96d-a783-e063-6294a90a97962025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3762f132-4ab0-74ad-e063-6394a90a436c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37637e45-c6ed-12ca-e063-6294a90aeb022025-12-11Exact identifier
application number: M020
Face and Body SunscreenZINC OXIDESCIENCE CEUTICALS, LLC369b42f3-5203-87c4-e063-6394a90a62842025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a32097-de93-9b1d-e063-6394a90a41df2025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3764856a-98c5-334e-e063-6394a90a629d2025-12-11Exact identifier
application number: M020
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a3e268-e376-11a0-e063-6294a90a46af2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
application number: M020
Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC374fae34-41b9-4cab-e063-6394a90a9b1d2025-12-11Exact identifier
application number: M020
Z BlocZINC OXIDEThe Maui Medical Group, Inc34b64eb5-a91f-de43-e063-6294a90a80432025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
application number: M020
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC375008f2-8dd4-aa31-e063-6394a90a5be82025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85634-212-45856340212451 CYLINDER in 1 CARTON (85634-212-45) / 4.5 g in 1 CYLINDER1 cylinder2023-04-11NoNoCurrent