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: 2027-12-31

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 151 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30	LIP BALM SPF30	Everyday Group Limted	2d42034a-4ada-57cf-e063-6394a90a0b5f	2025-12-04	Warnings	Exact identifier application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	3bb54b93-0ab2-2ecc-e063-6394a90acac3	2025-12-04	Warnings	Exact identifier application number: M020
Good Times SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	EVERYDAY GROUP LIMITED	f40c6c4a-47a2-5dfe-e053-2995a90a3df3	2025-12-04	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen	ZINC OXIDE	EVERYDAY GROUP LIMITED	3257719d-dcc6-7ac5-e063-6294a90aafcd	2025-12-04	Warnings	Exact identifier application number: M020
Sun Glazed SPF 30 Sunscreen Glow Oil	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	EVERYDAY GROUP LIMITED	dba8075b-be36-4787-b23d-942d0e792aa8	2025-12-04	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Deep	ZINC OXIDE	Crunchi, LLC.	0dc478e0-9555-4ce6-b448-7d58e3a6bae0	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Shield SPF40	SOLBAR SHIELD SPF40	Person and Covey	bd3a9a94-fc87-4127-abf9-29e56ac9ce5d	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Thirty SPF 30	SOLBAR THIRTY SPF30	Person and Covey	ab9ac056-61d9-43d5-a3db-2d487897cc69	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Fifty SPF50	SOLBAR FIFTY SPF50	Person and Covey	41fd3844-181c-4cb2-8379-f313104351ef	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Avo SPF35	SOLBAR AVO SPF35	Person and Covey	bfe1e828-76d4-4db3-a8ba-b54b31baacad	2025-12-04	Warnings	Exact identifier application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip Balm	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	c7a3c03b-7fee-404c-e053-2a95a90a3a97	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30	HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4524129b-f8aa-171b-e063-6294a90aeebe	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Zinc SPF38	SOLBAR ZINC SPF38	Person and Covey	fac62a2f-92ee-4afd-9999-bc5011159e43	2025-12-04	Warnings	Exact identifier application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl	ZINC OXIDE	e.l.f. Cosmetics, Inc.	6c316ce4-c2f6-4633-a789-e786d0f76abd	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b5f2c-b61f-8915-e063-6294a90ac911	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip gloss	HOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6e12-1bf9-8093-e063-6394a90a9e74	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b6f22-5080-86ab-e063-6394a90a0416	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Golden Hour SPF15 sunscreen lip oil	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8393-1887-a660-e063-6394a90a4c2b	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gel	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b8dde-dd63-b585-e063-6394a90a3543	2025-12-04	Warnings	Exact identifier application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	452b9b7d-4049-b483-e063-6394a90a5358	2025-12-04	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