FDA.reportPublic FDA data

DRMTLGY Lip Silk - Bold

Product NDC
83286-140
11-digit product format
832860140
Labeler code
83286
Product ID
83286-140_52be8585-1e63-a82a-e063-6394a90a0065
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
DRMTLGY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-30
Substance
ZINC OXIDE
Active strength
132 mg/mL
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
DRMTLGY Lip Silk - Bold
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
52be6cdf-9ee5-6ce5-e063-6294a90a6075Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-140-01DRMTLGY Lip Silk - Bold3.5 mL in 1 BOTTLE, WITH APPLICATORLOTION3.51
83286-140-02DRMTLGY Lip Silk - Bold1 in 1 CARTONLOTION11

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 60 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs2e20c132-8a03-1d5d-e063-6394a90ad2c32026-02-25WarningsExact identifier
application number: M020
Rationale The Brilliance Tinted Serum SPF 50ZINC OXIDERATIONALE GROUP PTY LTD5c38506b-1533-435f-87a6-0452bae5b29f2026-02-24WarningsExact identifier
application number: M020
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-140-01832860140013.5 mL in 1 BOTTLE, WITH APPLICATOR3.5 mlHistorical
83286-140-02832860140021 BOTTLE, WITH APPLICATOR in 1 CARTON (83286-140-02) / 3.5 mL in 1 BOTTLE, WITH APPLICATOR (83286-140-01) 2024-10-30NoNoCurrent