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	2026-10-21
excluded package	package	44099-011	44099-011-04	D	Discontinued by firm	2026-10-21
excluded package	package	44099-011	44099-011-05	D	Discontinued by firm	2026-10-21

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 37 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF Lip Colour	ZINC OXIDE	Lauren Brooke Cosmetiques, LLC	50b344b5-e39d-48ef-e063-6394a90ae41c	2026-04-30	Warnings	Exact identifier application number: M020
No 7 Prime Forever SPF 50 Primer	NO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMER	Boots Retail USA	50b3e9fa-faf8-0026-e063-6294a90a0823	2026-04-30	Warnings	Exact identifier application number: M020
Tru Skin Rituals SPF 25	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	f725cd5c-999e-2393-e053-6394a90a09dc	2026-04-30	Warnings	Exact identifier application number: M020
Moisture Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	cb95975f-060d-23c2-e053-2a95a90adf1b	2026-04-30	Warnings	Exact identifier application number: M020
Day Cream SPF 30	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Anthony Skin LLC	5070e8cc-12c0-c2c4-e063-6294a90a1422	2026-04-29	Warnings	Exact identifier application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30	ZINC OXIDE	HRR Enterprises, Inc	0eb122d8-6826-4843-bed1-9e0cb8316e6d	2026-04-29	Warnings	Exact identifier application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walmart	509b6c7d-8a28-2d3a-e063-6394a90af068	2026-04-29	Warnings	Exact identifier application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30	FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30	THE FREAKS OF NATURE, INC.	509b8610-6dbe-611f-e063-6394a90a9fd1	2026-04-29	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509cad98-0321-2a0a-e063-6294a90a6ea9	2026-04-29	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d7206-0cc1-c997-e063-6294a90a89e0	2026-04-29	Warnings	Exact identifier application number: M020
COTZ FACE MOISTURE	ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d9a74-bc8d-c9c1-e063-6394a90a403d	2026-04-29	Warnings	Exact identifier application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GPNY CORP	212d4563-2fad-31a5-e063-6394a90aff71	2026-04-29	Warnings	Exact identifier application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	GPNY CORP	211dea04-faad-8ffc-e063-6294a90a8d68	2026-04-29	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	5e19577b-9911-4fa1-a2b7-7ca2e02d1fd8	2026-04-28	Warnings	Exact identifier application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Ultraceuticals Pty Ltd	50888d3f-46ae-e2c2-e063-6394a90ad6af	2026-04-28	Warnings	Exact identifier application number: M020
Anything SPF	OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE	Anything SPF LLC	508b8dcb-6600-6dad-e063-6294a90a565a	2026-04-28	Warnings	Exact identifier application number: M020
Fusion Water Magic	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	ISDIN Corp.	d4f91d5a-600a-4255-a6e1-e7e7197848c7	2026-04-28	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c6a1b995-1898-4a92-b128-7d5ebd6d8d3d	2026-04-28	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Antioxidant Protocol	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	53023b16-8d64-4dfc-bc75-b4f248425c4d	2026-04-27	Warnings	Exact identifier application number: M020
TONEfitSUN Sebum Control Vegan Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory	506b96ae-eb2a-edad-e063-6294a90a470e	2026-04-27	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