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	2026-10-27
excluded package	package	44099-011	44099-011-04	D	Discontinued by firm	2026-10-27
excluded package	package	44099-011	44099-011-05	D	Discontinued by firm	2026-10-27

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 68 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink Ice	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ea23616f-1d59-4e32-88bb-d035af727728	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic Twist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	21b6239b-26d0-4b6b-8aee-fe1f20d8aaea	2026-01-27	Warnings	Exact identifier application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla Icing	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	483b6873-fe58-4a38-bf82-df116617c5f0	2026-01-27	Warnings	Exact identifier application number: M020
Zinc Oxide 20%	SUNSCREEN SPF 50 MINERAL	S&C Hampton Sun	4960930e-a1bf-d850-e063-6294a90a4084	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier application number: M020
Golden Glow SHIMMER MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	4963e513-d1fc-4b0e-e063-6394a90a7ddf	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO	LE COSMETICS INC	49643a56-3627-67f8-e063-6294a90a2d7b	2026-01-27	Warnings	Exact identifier application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS	LE COSMETICS INC	49644002-153e-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	496ba4c4-6577-88ff-e063-6294a90a0995	2026-01-27	Warnings	Exact identifier application number: M020
Vacation Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	b442530f-cae3-418b-9675-c18879653826	2026-01-27	Warnings	Exact identifier application number: M020
EltaMD UV Clear Blemish-Prone and Oil Balancing	OCTINOXATE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6337b9e3-2524-4292-8fc8-1f6aad6cfe05	2026-01-27	Warnings	Exact identifier application number: M020
SPF Ginger Sunscreen SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SPF GINGER LLC	f303ad78-5fa3-40d1-9b1c-53ae1ca73aed	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	8506049f-cb43-4d1d-885b-c6d3a99bbba3	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP COCO-MANGO SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	144178e7-2df9-49c3-9667-43986cee89c4	2026-01-26	Warnings	Exact identifier application number: M020
ALOE KOTE SPF 25	OCTINOXATE, OXYBENZONE, HOMOSALATE	Aloe Care International, LLC	12e78c53-ba19-4c8e-bd2f-8c85fccbc179	2026-01-26	Warnings	Exact identifier application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	62016e94-b5d2-4ba2-ab9c-b0b2c1ead650	2026-01-26	Warnings	Exact identifier application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%	SPF 45 FACE	S&C Hampton Sun LLC	e49808c9-5025-4965-8679-7fe824cf6907	2026-01-26	Warnings	Exact identifier application number: M020
ENVIRONMENTAL DEFENSE	ZINC OXIDE	Avasol LLC	1fbddab4-71f7-4167-ad21-30040b7c71bb	2026-01-26	Warnings	Exact identifier application number: M020
Surfers Barrier	ZINC OXIDE	Avasol LLC	d6e2ac0a-3bf6-4d08-8647-6a23de2ac857	2026-01-26	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