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
Ingredient	Strength
ZINC OXIDE	132 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
52be6cdf-9ee5-6ce5-e063-6294a90a6075	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83286-140-01	DRMTLGY Lip Silk - Bold	3.5 mL in 1 BOTTLE, WITH APPLICATOR	LOTION	3.5		1
83286-140-02	DRMTLGY Lip Silk - Bold	1 in 1 CARTON	LOTION	1		1

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 312 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Tekweld Solutions, Inc.	ea9f4d57-b00c-48ce-b833-9690be98bffd	2023-12-26	Warnings	Exact identifier application number: M020
Best Skin Days BS SPF 30	ZINC OXIDE	Allure Labs	0d7072f8-e808-5270-e063-6294a90a1ffa	2023-12-26	Warnings	Exact identifier application number: M020
Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f0d6518b-d795-4740-a301-1804a932ec45	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	L'Oreal USA Products Inc	4f4a8c37-af08-4bf7-89bc-1e487417c146	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow	OCTINOXATE	SICOS ET CIE	7051f505-f874-4214-ad4f-55a956cc35a7	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	08645f1d-7ba7-4410-8600-3d3f79d71385	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	fc847725-b7a9-41f1-a605-d1d892fed06f	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin Types	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	df67b49c-f8b6-4c0a-9e8d-c94dee3635ff	2023-12-23	Warnings	Exact identifier application number: M020
Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	a9b7e52c-8799-49ba-8b05-7559fe6668fe	2023-12-23	Warnings	Exact identifier application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fair	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	32569352-c51e-4f05-a8b0-749ef916a5af	2023-12-22	Warnings	Exact identifier application number: M020
Circadia Circa-Shield Mineral Sunscreen SPF 30	ZINC OXIDE	Circadia by Dr Pugliese, Inc.	2959aa56-be7f-4721-9701-e6d6e12cc850	2023-12-22	Warnings	Exact identifier application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc	0adb52f5-4e1f-4570-9b6f-584e4da61d9f	2023-12-22	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	ESTEE LAUDER INC	c670635a-63d8-4b0b-afd7-b26e969f93a1	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutral	TITANIUM DIOXIDE	Tarte, Inc.	62fffef6-29ae-4137-b0b9-fb93d6167933	2023-12-21	Warnings	Exact identifier application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutral	TITANIUM DIOXIDE	Tarte, Inc.	889860fc-7fce-47e9-af28-a3b2aec04a0e	2023-12-21	Warnings	Exact identifier application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Ascendant Beauty LLC	cba4e886-c4c6-4377-8f4c-250aef4b95fb	2023-12-21	Warnings	Exact identifier application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	d12e30bd-88ee-4e34-ae63-c34766aed3a8	2023-12-20	Warnings	Exact identifier application number: M020
COOLA Liplux Hydrating Oil SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	2d2ad94c-ea13-43c0-ab7f-acecf4d2309f	2023-12-20	Warnings	Exact identifier application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%	COOLA LLC	a334a61d-5c5a-4f45-b202-6dd7bb3d250b	2023-12-20	Warnings	Exact identifier application number: M020
Bare Republic Big Adventure Stick SPF 70	TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%	COOLA	e800f72f-8c8b-4a12-843f-1ee404055cf0	2023-12-20	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83286-140-01	83286014001	3.5 mL in 1 BOTTLE, WITH APPLICATOR	3.5 ml				Historical
83286-140-02	83286014002	1 BOTTLE, WITH APPLICATOR in 1 CARTON (83286-140-02) / 3.5 mL in 1 BOTTLE, WITH APPLICATOR (83286-140-01)		2024-10-30	No	No	Current