Sunscreen

Product NDC: 55550-102
11-digit product format: 555500102
Labeler code: 55550
Product ID: 55550-102_1a647efd-f17c-44f1-ab72-974603f42bf7
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octinoxate, Octisalate, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: Total Resources International
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-20
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55550-102-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55550-102-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55550-102-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55550-102-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	6 mg/g
OCTINOXATE	7.5 mg/g
OCTISALATE	5 mg/g
OXYBENZONE	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	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
7d4f820d-e154-428e-89c2-2e26e088ceef	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55550-102-01	2023-01-26	C162847	48780-1	ba0f9c33-2171-a910-e053-dadaa90a0b85	Sunscreen
55550-102-01	2021-01-29	C162847	48780-1	ba0f9c33-2171-a910-e053-dadaa90a0b85	Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55550-102-01	Sunscreen	1.5 g in 1 PACKET	LOTION	1.5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Homosalate	ACTIVE MOIETY	V06SV4M95S	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
polyoxyl 40 stearate	INACTIVE INGREDIENT	13A4J4NH9I	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
povidone K30	INACTIVE INGREDIENT	U725QWY32X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55550-102	SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]	4	Current NDC, Legacy NDC, 1 package rows	20241228_7d4f820d-e154-428e-89c2-2e26e088ceef.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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Preen Screen Broad Spectrum SPF 50	AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Grace and Fire USA Inc.	26a0fc0d-a903-2ac1-e063-6394a90a13db	2026-06-01	Warnings	Exact identifier application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	ProBetter USA, Inc.	82a22071-f1bd-4fab-b929-8a00ef18f0d9	2026-05-31	Warnings	Exact identifier application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	OSEA International, LLC	9aa20377-0ab9-4205-b9aa-24640a4641e7	2026-05-29	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Sugar	ZINC OXIDE	Ciele LLC	52f3a9f6-a226-6723-e063-6394a90a8706	2026-05-29	Warnings	Exact identifier application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier application number: M020
Daily Mineral Sunscreen 20% Zinc Oxide	ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	52f818f4-8485-b228-e063-6294a90a9fe3	2026-05-29	Warnings	Exact identifier application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREEN	ZINC OXIDE, OCTISALATE, HOMOSALATE	GOWOONSESANG COSMETICS CO., LTD.	30d34459-b7fb-b0c6-e063-6294a90a08ac	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN	ZINC OXIDE	GOWOONSESANG COSMETICS CO., LTD.	30d49f24-3e13-385f-e063-6294a90ab5c8	2026-05-28	Warnings	Exact identifier application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN	HOMOSALATE, OCTISALATE, AVOBENZONE	GOWOONSESANG COSMETICS CO., LTD.	30d53b8a-7e35-0b2b-e063-6294a90aa8df	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e16cbc-b452-db18-e063-6394a90a4081	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect June	ZINC OXIDE	Ciele LLC	52e1c504-f0ee-2853-e063-6394a90a3139	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect January	ZINC OXIDE	Ciele LLC	52e186df-06aa-6528-e063-6294a90a3888	2026-05-28	Warnings	Exact identifier application number: M020
Ciele Blush and Protect Berri	ZINC OXIDE	Ciele LLC	52e1398d-b170-ea89-e063-6294a90a7d24	2026-05-28	Warnings	Exact identifier application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREEN	ZINC OXIDE 20%	Fallien Cosmeceuticals, LTD	30d30610-2e6c-418c-bbcf-4ecd7f61be93	2026-05-28	Warnings	Exact identifier application number: M020
Creme Foundation	ZINC OXIDE	Lauren Brooke Cosmetiques LLC	4d09907e-ddcd-9d62-e063-6394a90acf3f	2026-05-28	Warnings	Exact identifier application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8720b4-5e8b-dc8b-e063-6394a90aad34	2026-05-27	Warnings	Exact identifier application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50	ZINC OXIDE	Zero to Seven Inc.	1e8727a4-0dc0-19dc-e063-6394a90a82b6	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and Sol SUNSCREEN SPF30	NON-NANO ZINC OXIDE 20%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52c9dc0a-41f7-3e8a-e063-6394a90a8fca	2026-05-27	Warnings	Exact identifier application number: M020
Tallow and SolSUNSCREEN SPF50	NON-NANO ZINC OXIDE 25%	Guangzhou Shengyanghui Industrial Trading Co., Ltd	52cb56cf-f092-9f86-e063-6394a90ac2d3	2026-05-27	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Face and Body	ZINC OXIDE	Toddle Born Wild, Inc.	e97d82fe-cd45-43a5-9c1f-3900025240a1	2026-05-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55550-102-01	55550010201	1.5 g in 1 PACKET (55550-102-01)	1.5 g	2023-01-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunscreen	Total Resources International \| Safetec of America, Inc.	2024-12-20	HUMAN OTC DRUG LABEL	4