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	2026-10-20
excluded package	package	44099-011	44099-011-04	D	Discontinued by firm	2026-10-20
excluded package	package	44099-011	44099-011-05	D	Discontinued by firm	2026-10-20

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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bath and Body Works SPF Coconut	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	56078491-f7d6-97f7-e063-6394a90a6deb	2026-07-07	Warnings	Exact identifier application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxide	ZINC OXIDE	Surprise Enterprise LLC	38cf4325-9720-f511-e063-6394a90ad628	2026-07-07	Warnings	Exact identifier application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	560c0f35-2132-52a6-e063-6394a90a2d24	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Bonnie	CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE	Delicate Cosmetics Inc	560d1d19-87a6-179b-e063-6294a90ada5e	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Kelly	CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY	Delicate Cosmetics Inc	560df34a-e6da-0792-e063-6394a90a7e71	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLou	CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU	Delicate Cosmetics Inc	560e37ae-87c0-39d2-e063-6394a90a2af4	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Cassette	CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE	Delicate Cosmetics Inc	560e4198-b07c-3d48-e063-6394a90a7be3	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Margaux	CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX	Delicate Cosmetics Inc	560e47d5-c881-438c-e063-6394a90a3091	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Saddle	CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE	Delicate Cosmetics Inc	560e5de5-1350-4046-e063-6394a90abffa	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Puzzle	CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE	Delicate Cosmetics Inc	560e5558-8e46-7736-e063-6294a90acb05	2026-07-07	Warnings	Exact identifier application number: M020
EELHOE Body Coverage Perfector	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5610c3b7-456b-3bc1-e063-6394a90a3fa8	2026-07-07	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	1d4be26a-4695-491c-85d1-86824e1cd029	2026-07-06	Warnings	Exact identifier application number: M020
SPF 30 Sunscreen	HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%	Coconut Caliente Costa Rica LLC	71856cb3-9386-4569-80e4-92826342e386	2026-07-06	Warnings	Exact identifier application number: M020
Stay Ageless Sunscreen	BROAD SPECTRUM SPF 30	TOXFAIRY, LLC	55f7e07e-1689-6d38-e063-6294a90a9119	2026-07-06	Warnings	Exact identifier application number: M020
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Emerald Aesthetics LLC	55f88dd1-346c-22a5-e063-6294a90a711f	2026-07-06	Warnings	Exact identifier application number: M020
RR Sun	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	87244432-2967-4145-89cd-11a7567083a3	2026-07-06	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	35af90d3-dfe1-30dc-e063-6294a90a10a5	2026-07-05	Warnings	Exact identifier application number: M020
MDP PEPTIDE 9 BIO SUN PRO	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	SKINIDEA CO., LTD	26db53cd-dd82-8790-e063-6394a90a92b1	2026-07-03	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Theravita LLC	d8e276cc-0292-499d-9075-a83a2d3fafcc	2026-07-02	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	5880b275-91fc-4589-a076-0e55409425d8	2026-07-02	Warnings, Adverse reactions	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