FDA.reportPublic FDA data

Mineral Sunscreen Lip

Product NDC
85372-212
11-digit product format
853720212
Labeler code
85372
Product ID
85372-212_4627750c-bc7d-ce6e-e063-6394a90ae28b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Glow Advanced Skin and Body Care, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-13
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40; 55 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 Sunscreen Lip
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
36362dc7-31d7-f766-e063-6294a90a129bAvailable 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
85372-212-45Mineral Sunscreen Lip4.5 g in 1 CYLINDERSTICK4.52
85372-212-45Mineral Sunscreen Lip1 in 1 CARTONSTICK12

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 147 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenishing Daily Protection Sunscreen InvisibleZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32462e88-0e74-a675-e063-6294a90ac5642025-12-08Exact identifier
application number: M020
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
application number: M020
Mineral Based Foam Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32486bfb-0cc8-0283-e063-6394a90a99672025-12-08Exact identifier
application number: M020
Harrys Daily Facial SPF Broad SpectrumZINC OXIDEHarry's, Inc.39fdde34-45ec-bc22-e063-6394a90a7dce2025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Brightening plus TintZINC OXIDEZEN DERMATOLOGY, INC.31e32e9c-9e0b-b678-e063-6294a90a66f52025-12-08Exact identifier
application number: M020
Healthy Mineral Sunscreen No Shine plus TintZINC OXIDEZen Dermatology, Inc.31576340-cb11-d944-e063-6294a90adef22025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen No Shine - No TintTITANIUM DIOXIDE, ZINC OXIDEZen Dermatology, Inc.31572a16-5f60-565f-e063-6394a90ab8c92025-12-08WarningsExact identifier
application number: M020
Healthy Mineral Sunscreen Face and BodyZINC OXIDEZen Dermatology, Inc.31e376b4-098f-34d7-e063-6394a90a17722025-12-08Exact identifier
application number: M020
AcneFix Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.315894b7-ac1b-0982-e063-6294a90ab8792025-12-08Exact identifier
application number: M020
Shunly Natural Cover SPF50TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Carea64e373b-b3f6-4024-b5f5-253783485cd62025-12-08WarningsExact identifier
application number: M020
AcneFix Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEACNEFIX INC.31583c7e-365a-d899-e063-6394a90aa63f2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334ec844-5560-50f7-e063-6394a90a01be2025-12-08Exact identifier
application number: M020
Mineral Fusion TintedTITANIUM DIOXIDE, ZINC OXIDEFOREFRONT DERMATOLOGY, S.C.334f90d6-68e5-db37-e063-6294a90a5fb12025-12-08Exact identifier
application number: M020
Skin Apeel Pure Protect SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.18e78c7f-1523-a4f4-e063-6394a90aed972025-12-08WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
application number: M020
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
application number: M020
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
application number: M020
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
application number: M020
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
application number: M020
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85372-212-45853720212451 CYLINDER in 1 CARTON (85372-212-45) / 4.5 g in 1 CYLINDER1 cylinder2022-05-13NoNoCurrent