FDA.reportPublic FDA data

DRMTLGY Lip Silk - Soft

Product NDC
83286-139
11-digit product format
832860139
Labeler code
83286
Product ID
83286-139_52be93c3-9ea9-a7b2-e063-6394a90a506e
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 - Soft
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
52be975c-6a2a-cf21-e063-6294a90a7c1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
83286-139-01DRMTLGY Lip Silk - Soft3.5 mL in 1 BOTTLE, WITH APPLICATORLOTION3.51
83286-139-02DRMTLGY Lip Silk - Soft1 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 175 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - CocoaHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.40e6473a-8363-4503-bde0-6c151296fb342025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7f4a185c-85c7-43bf-8695-c01a3aecec0d2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - NaturalHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V383aabdf-3feb-4407-9d85-27c11cb3e78c2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - ShellHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V4585b1c8-e477-44d7-a3ad-a9efc3d699b72025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V1e9efb61-06ad-4d2d-a81d-46aba72f75142025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- BisqueHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.Vffc421e1-26eb-44e7-b03c-5fab761a51b22025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V3617d26e-a94c-4665-988b-95dbbc5270172025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- HoneyHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.55be05c0-429a-4ae0-bb86-1120bb1905ff2025-10-21WarningsExact identifier
application number: M020
Sun face protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e1ced7-dafa-c71e-e053-2995a90a95502025-10-21WarningsExact identifier
application number: M020
Jafra Sun sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b9316e16-c571-4a5c-e053-2995a90ac6a82025-10-21WarningsExact identifier
application number: M020
Jafra Sun tinted face protector sunscreen broad spectrum 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8df67f8-57d9-ddc1-e053-2995a90a50c62025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
application number: M020
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC4198cfc0-a696-e279-e063-6294a90ac2392025-10-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-139-01832860139013.5 mL in 1 BOTTLE, WITH APPLICATOR3.5 mlHistorical
83286-139-02832860139021 BOTTLE, WITH APPLICATOR in 1 CARTON (83286-139-02) / 3.5 mL in 1 BOTTLE, WITH APPLICATOR (83286-139-01) 2024-10-30NoNoCurrent