skin MD

Product NDC: 44099-011
11-digit product format: 440990011
Labeler code: 44099
Product ID: 44099-011_4384c3d1-e160-67fa-e063-6394a90a0a42
Type: HUMAN OTC DRUG
Nonproprietary name: octinoxate, octisalate, homosalate
Dosage form: LOTION
Route: TOPICAL
Labeler: 21st Century Formulations
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-08-19
Substance: OCTINOXATE; OCTISALATE; HOMOSALATE
Active strength: 7; 5; 3 mg/100mL; mg/100mL; mg/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	44099-011	44099-011-03	D	Discontinued by firm	2026-10-23
excluded package	package	44099-011	44099-011-04	D	Discontinued by firm	2026-10-23
excluded package	package	44099-011	44099-011-05	D	Discontinued by firm	2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44099-011-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44099-011-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	44099-011-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44099-011-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44099-011-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44099-011-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44099-011-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	44099-011-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44099-011-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44099-011-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44099-011-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44099-011-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	44099-011-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: skin MD
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	7 mg/100mL
OCTISALATE	5 mg/100mL
HOMOSALATE	3 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
V06SV4M95S	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
e809e1d3-0a6d-730d-e053-2a95a90aedb9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
44099-011-01	skin MD	117 mL in 1 BOTTLE	LOTION	117	7
44099-011-02	skin MD	236 mL in 1 BOTTLE	LOTION	236	7
44099-011-03	skin MD	3785 mL in 1 BOTTLE	LOTION	3785	7
44099-011-04	skin MD	100 mL in 1 TUBE	LOTION	100	7
44099-011-05	skin MD	200 mL in 1 TUBE	LOTION	200	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44099-011	SKIN MD (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [21ST CENTURY FORMULATIONS]	6	Current NDC, Legacy NDC, 5 package rows	20250406_e809e1d3-0a6d-730d-e053-2a95a90aedb9.zip

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 61 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	Saltair Body LLC	4b9ac780-ef7d-42fc-e063-6394a90ad62f	2026-02-24	Warnings	Exact identifier application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	Saltair Body LLC	4b9b36a6-4da9-8439-e063-6394a90aa86b	2026-02-24	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Shiseido Americas Corporation	b93f10dc-193d-4cda-94b6-3f0e54d89f21	2026-02-23	Warnings	Exact identifier application number: M020
cle de peau BEAUTE ADVANCED PROTECTIVE DAY	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	710975d8-43bf-40b9-82c2-d4dc2988956d	2026-02-23	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR MINERAL	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	5e31eee8-6532-47ea-99fc-22418791804b	2026-02-23	Warnings	Exact identifier application number: M020
Eryfotona Ageless	ZINC OXIDE	ISDIN Corp.	a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f	2026-02-23	Warnings	Exact identifier application number: M020
Perfect Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN PERFECT MEDICAL	4b47e7cb-17d6-6a7c-e063-6294a90abbea	2026-02-20	Warnings	Exact identifier application number: M020
Beauty Hydrating	HOMOSALATE, ZINC OXIDE	Meijer, Inc.	69b72139-757f-476d-99d2-33f5524c41d2	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M020
daily moisturizer	AVBENZONE, OCTISALATE, OCTOCRYLENE	Meijer, Inc.	6d301146-46e0-445c-b14e-3ec8ce76cb45	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer, Inc.	e9f4a2bb-d21e-4b38-9a37-23c23c8ad857	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M020
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Ink-eeze	3f759bec-4e33-46fa-a800-fa3a17d63df9	2026-02-19	Warnings	Exact identifier application number: M020
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42	TITANIUM DIOXIDE, ZINC OXIDE	ALLAY SKIN SOLUTIONS LLC	425bf1d7-f2cf-4237-9047-dd53054acd1c	2026-02-18	Warnings	Exact identifier application number: M020
e.l.f. Best and Obsessed Skincare Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	4b1c1150-5ac5-4a8b-e063-6394a90a5410	2026-02-18	Warnings	Exact identifier application number: M020
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN	TITANIUM DIOXIDE	S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE	dacff3dc-49d7-6416-e053-2a95a90a85c6	2026-02-18	Warnings	Exact identifier application number: M020
Degree Clinical	COOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANT	Conopco Inc. d/b/a/ Unilever	4b1f9fd3-3c49-9a98-e063-6294a90a20e0	2026-02-18	Warnings	Exact identifier application number: M020
e.l.f. Wake the E.L.F. Up Skincare Set	AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE	e.l.f. Cosmetics, Inc	4b20c56a-3e91-3419-e063-6294a90ad361	2026-02-18	Warnings	Exact identifier application number: M020
Dermatone Mineral SPF 30	ZINC OXIDE 20%	Dermatone Labs LLC	26e3209f-cb5c-484e-9b2e-74dc397d4790	2026-02-18	Warnings	Exact identifier application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAY	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	8b88039a-09fe-458b-b80f-49cde49b6595	2026-02-17	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f3729d0b-e601-48bb-9907-1d6e3ab31996	2026-02-17	Warnings	Exact identifier application number: M020
Luminesce Daily Moisturizing Complex	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Velovita Inc.	4b0c2213-8667-be6f-e063-6394a90a5e86	2026-02-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44099-011-01	44099001101	117 mL in 1 BOTTLE (44099-011-01)	117 ml	2008-08-19	0000-00-00	No	No	Current
44099-011-02	44099001102	236 mL in 1 BOTTLE (44099-011-02)	236 ml	2008-08-19	0000-00-00	No	No	Current
44099-011-03	44099001103	3785 mL in 1 BOTTLE (44099-011-03)	3785 ml	2008-08-19	0000-00-00	No	No	Current
44099-011-04	44099001104	100 mL in 1 TUBE (44099-011-04)	100 ml	2018-07-16	0000-00-00	No	No	Current
44099-011-05	44099001105	200 mL in 1 TUBE (44099-011-05)	200 ml	2018-07-16	0000-00-00	No	No	Current