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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30ZINC OXIDEAllure Labs11fce5ec-66e8-9eac-e063-6394a90aaf3a2024-02-22WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%Meijer074b6340-0482-ab05-e063-6294a90adedb2024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.11c37acc-abb8-8c38-e063-6294a90a79322024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltd11c461f7-0f34-65ff-e063-6294a90a3da72024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c61b92-89f4-692f-e063-6394a90a69cd2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c651e2-072e-770e-e063-6394a90ad6fa2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c65e7f-fe11-8115-e063-6394a90a85942024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c6cf95-8923-af79-e063-6294a90a4f442024-02-19WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.118842ce-9d9b-80ce-e063-6394a90ab9862024-02-16WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11894c1d-c199-dfc0-e063-6394a90a3f152024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.711aa92c-81b0-42e4-b83f-9ce95116ec032024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Meijer075dddd5-46ea-282a-e063-6294a90a28fd2024-02-15WarningsExact identifier
application number: M020
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
application number: M020
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
application number: M020
Weightless Protection SPF 45SUNSCREEN BROAD SPECTRUMCP Skin Health Group, Inc.b6bee26d-bffd-a8ee-e053-2a95a90affc52024-02-14WarningsExact 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