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 293 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Care SPF 30 Facestick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONENaples Soap Co.1cfb91dc-178e-fd5d-e063-6394a90a53002024-07-11WarningsExact identifier
application number: M020
the beach people SPF 15ZINC OXIDEThe Beach People United LLC60c97b25-a23d-4f8f-bc20-0a312cbcde0e2024-07-11WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-COCTINOXATE, ZINC OXIDEBEL STAR S A1cec29ae-d402-0ee7-e063-6394a90a0a892024-07-10WarningsExact identifier
application number: M020
5298 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties667dccd6-5047-4beb-b2f0-0b8d8d79aa012024-07-10WarningsExact identifier
application number: M020
5283 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties3a06bb05-5965-4d7d-a299-3d48b163c6042024-07-10WarningsExact identifier
application number: M020
5281 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties86fc4539-e1c5-4d0f-a418-f48729cb2b202024-07-10WarningsExact identifier
application number: M020
5299 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3db6bd8-cc6f-4af5-809d-95fb05f6732f2024-07-10WarningsExact identifier
application number: M020
5407 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3f86164-2a2e-4f1f-a562-c1ff6cf503222024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.1bbf3712-b59d-cf6d-e063-6294a90af9b72024-07-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 BANANA SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5f02688-cb8a-4d9b-e053-2995a90ad1ba2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5ef831e-7c28-7c85-e053-2995a90a9e022024-07-08WarningsExact identifier
application number: M020
Equaline Sport Continuous Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENESUPERVALU INC.1cc23322-2570-75ab-e063-6394a90ad2892024-07-08WarningsExact identifier
application number: M020
Equaline Zinc Oxide Sunscreen Stick SPF 50ZINC OXIDEUnited Natural Foods, Inc. dba UNFI1cc27f99-82f3-7aee-e063-6294a90a6f372024-07-08WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a8f5d5-d3c7-4a6f-e063-6294a90a94e32024-07-02WarningsExact identifier
application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip BalmZINC OXIDEElemental Herbs, Inc.fdf17ffa-681b-2809-e053-6394a90a5b6e2024-07-02WarningsExact identifier
application number: M020
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
application number: M020
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact 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