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 78 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4dbfd77-0eec-4d1a-94d6-4daca096d8c72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72569958-cd7d-4d52-add4-2b13706e1b1e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0f5aa600-4168-419b-95d7-569764b5f0b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore5ab0cd9-ae7f-4558-b5ab-e0b5826772242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9fa3bb9-12ec-40d8-b433-a96d9d00cc902026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf7b2e348-2c7f-4ff5-8ab0-a3475c9d1f262026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior69924eb8-a8ca-4ea0-b087-c865a6a1313f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5cafac21-fb2d-4d63-a7fe-01bf53b941e82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbfc27e8d-e59b-46f7-aec9-2a96a00a7c1c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8fd56c86-ef37-4f31-87d1-6283a19c84242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior91b62ba7-2deb-47e6-b9af-25bb459b4d752026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6eec7554-38ed-48d4-916d-ab3660fbf7032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior939e6d5c-3dd7-4b01-af18-697dc4ba2d992026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7149784b-3548-4643-abf6-58fde237bb982026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior061181d8-5387-4541-a7d7-426cba5997a02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6ad554a-4795-4149-b066-c53a0989470e2026-01-16WarningsExact 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