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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunscreen Lotion118mL	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46355437-4068-9d03-e063-6394a90ae52c	2026-01-09	Warnings	Exact identifier application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30	SUNCARE FACE SUNSCREEN SPF30	Aopline Biotechnology (Guangzhou) Co., Ltd.	47f26af6-4d02-3506-e063-6294a90a0fe6	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care Carrot	OCTINOXATE	Farmasi US LLC	67de9257-70f3-4444-a4a2-a8d7425fcc0e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad Spectrum	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	d9197dce-20a3-4d10-807c-ec84ab902165	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Lumi Radiance Brightening	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	adf5621b-7cf0-53b3-e053-2a95a90a8058	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15	HOMOSALATE, OCTINOXATE	FARMASI US LLC	1dbd5e83-2248-4751-88d9-b446ccc3c61e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	27fdbd2b-60de-4906-a176-5c5198d9925b	2026-01-09	Warnings	Exact identifier application number: M020
Skin Metal Stealth	ZINC OXIDE	Skin Metal	47f5d7de-5d32-041a-e063-6394a90ab6f9	2026-01-09	Warnings	Exact identifier application number: M020
Salt and Blue Body Sunscreen SPF 30	ZINC OXIDE 20%	Salt + Blue LLC	47f764a0-e9ad-ef66-e063-6394a90a8de5	2026-01-09	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Supergoop, LLC	61766f7b-512d-45b5-b652-e09975a3d3fc	2026-01-09	Warnings	Exact identifier application number: M020
Defense Refresh (Re)Setting Mist SPF 40	AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE	Supergoop LLC	b95ad8e3-978b-b721-e053-2a95a90a1e54	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	aed0dd03-1695-a5a9-e053-2995a90acfdc	2026-01-09	Warnings	Exact identifier application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972ebab9-3f2f-6716-e053-2a95a90a5c75	2026-01-09	Warnings	Exact identifier application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972c68e7-b137-34c6-e053-2a95a90a77d6	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ee045b64-7a95-4378-8183-e6e556f3b184	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	967d0657-18fc-4e4a-b52d-442df43329f1	2026-01-09	Warnings	Exact identifier application number: M020
PLAY SPF 30 Lip Shield Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0b8b850-bdfe-5563-e053-2995a90a51a7	2026-01-09	Warnings	Exact identifier application number: M020
Play SPF 30 Lip Shield Strawberry	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0a49142-53c3-5b7a-e053-2995a90a581d	2026-01-09	Warnings	Exact identifier application number: M020
Glow Stick Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	61e543e3-9ace-6440-e053-2991aa0a9647	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af5c9801-26ce-5c60-e053-2995a90ab457	2026-01-09	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