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 54 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	af052521-bfa6-4142-a10b-ef51f474a077	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	42647444-93a3-4d2c-9bfc-91621fd098f7	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Babies SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Nice-Pak Products, LLC	a4b9d7c0-dc09-4f0e-8b65-90ba180552bf	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M020
TINTED WATERY SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	KSISTERS PTE. LTD.	4ced53d0-8bfc-ff8e-e063-6294a90a9dbd	2026-03-13	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Mother s Day Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4cf03092-7886-ffa1-e063-6294a90a2aad	2026-03-13	Warnings	Exact identifier application number: M020
Daily Moisturizing Mineral Sunscreen	BROAD SPECTRUM SPF30	EDINA PLASTIC SURGERY,LTD.	4d056e2b-5813-da42-e063-6294a90ac519	2026-03-13	Warnings	Exact identifier application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra light	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	L'Oreal USA, Inc.	dad00eee-92cd-7610-e053-2a95a90a1fac	2026-03-13	Warnings	Exact identifier application number: M020
VITARAN REJUVENA SUNCARE	ALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATE	BR PHARM CO. , Ltd.	4cb7af72-49f6-0738-e063-6394a90a79eb	2026-03-12	Warnings	Exact identifier application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21	ZINC OXIDE, OCTISALATE, OCTOCRYLENE	PFD Co.,Ltd.	4cd0a8a7-11aa-e168-e063-6394a90a2ff2	2026-03-12	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Vi-Jon, LLC	3da4706e-7c1a-435e-9603-e9aa98432018	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	53806657-7b4d-45ff-a75b-9340dcd8140e	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Nice-Pak Products, LLC	08237b4c-4e5c-4b12-9510-2f8d64ab7f3a	2026-03-12	Warnings, Adverse reactions	Exact identifier application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 Fairfax	ZINC OXIDE	Tower 28	108851ac-3812-4c02-a04a-9f9a7f529ed6	2026-03-12	Warnings	Exact identifier application number: M020
DIY Booster SPF 30 Facial Serum Unscented	OCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDE	Andalou naturals	ebaf5ef7-84aa-4cb1-a701-2e0d0fd357df	2026-03-12	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation INC.	f268fb1c-d7c2-f2f9-e053-2995a90a9e22	2026-03-12	Warnings	Exact identifier application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C	TITANIUM DIOXIDE	Kenvue Brands LLC	4c335d9c-40ca-c0ce-e063-6394a90ac20a	2026-03-11	Warnings	Exact identifier application number: M020
CENTELLA SUNSCREEN Cream	ZINC OXIDE	Yunqi Cosmetics (Shenzhen) Co., Ltd	4cbac4e9-7540-f703-e063-6394a90ad808	2026-03-11	Warnings	Exact identifier application number: M020
Vacation Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	4ba8ed52-2f52-40b9-a810-8450f9b90778	2026-03-10	Warnings	Exact identifier application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free	ZINC OXIDE	COOLA LLC	4cad89a5-325c-b3c2-e063-6294a90ac225	2026-03-10	Warnings	Exact identifier application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 Sensitive	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	4caf2ab5-76cb-4b0f-e063-6294a90a233e	2026-03-10	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