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
2027-12-31
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
2027-12-31

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 209 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting BB Beauty Balm Natural Tint SPF 30ZINC OXIDEAndalou naturals16ca3790-9973-4a04-a43c-e0f7b384f1472025-06-11WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd.3690af2b-fe22-3a9a-e063-6294a90a709d2025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEPPacifica Beauty, LLC373901f7-0e32-0f32-e063-6394a90abe252025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TANPacifica Beauty, LLC37397b96-ef14-9098-e063-6294a90aafc92025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHTPacifica Beauty, LLC373aba7c-2ae1-8726-e063-6294a90ae3d82025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUMPacifica Beauty, LLC373c29b9-2f75-9777-e063-6394a90a68a62025-06-10WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
application number: M020
ALLIES OF SKIN The One SPF-50 Invisible SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.36e1c61c-33ab-4a5d-853d-119c29632b082025-06-09WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company372819f1-0813-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-ClearAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3806e2f2-ffd1-6d69-e063-6394a90acb442025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-GetawayAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3808613f-88d6-6c1a-e063-6294a90a5bb22025-06-09WarningsExact identifier
application number: M020
1000 Roses Daily Shade Facial SPF 18OCTISALATE, OCTOCRYLENE, AND AVOBENZONEAndalou naturals0923e090-6834-4373-80fe-21f00b8c1c172025-06-09WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun CushionZINC OXIDE, HOMOSALATE, OCTOCRYLENEADMTMAX LLC20afcbab-a2f4-7965-e063-6294a90a83d12025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Mild SunscreenZINC OXIDEADMTMAX LLC20ab5698-cd9f-0821-e063-6394a90a60d72025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun StickHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC20ae82ae-bc8f-89d1-e063-6394a90afff22025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Essence SunscreenHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC1ccfa213-2f83-ad50-e063-6294a90a38bf2025-06-08WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/MediumZINC OXIDEPacifica Beauty, LLC36ec6c9d-f7dc-0419-e063-6294a90a55e62025-06-06WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/FairZINC OXIDEPacifica Beauty, LLC36ed9101-249a-922c-e063-6394a90a26082025-06-06WarningsExact 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