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 19 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Not there spf broad spectrum spf40 moisturizer	AVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	546f0474-4102-26d0-e063-6394a90a388b	2026-06-17	Warnings	Exact identifier application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40	ZINC OXIDE	Grace and Fire USA Inc.	52d4b1c1-7431-4f8c-e063-6294a90ad482	2026-06-17	Warnings	Exact identifier application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30	ZINC OXIDE	Moes Group LLC	54751f23-5723-0407-e063-6294a90a4a96	2026-06-17	Warnings	Exact identifier application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	5478fb36-e972-f824-e063-6294a90a567f	2026-06-17	Warnings	Exact identifier application number: M020
Elaine Sterling Hydrating Sunscreen	ZINC OXIDE	Elaine Sterling Enterprises	5479e862-aca5-7541-e063-6394a90ad0c5	2026-06-17	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	545aa56a-ed07-acd6-e063-6394a90ae0c7	2026-06-16	Warnings	Exact identifier application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREEN	OCTISALATE	LOreal USA Products Inc	3b99ab06-ba4c-4ddd-a057-60028eedd67d	2026-06-16	Warnings	Exact identifier application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREEN	ZINCOXIDE	Moes Group LLC	54617bf2-1d8d-531e-e063-6294a90a7080	2026-06-16	Warnings	Exact identifier application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance Free	ZINC OXIDE	Ultraceuticals Pty Ltd	5461ee82-0297-ce22-e063-6294a90a729b	2026-06-16	Warnings	Exact identifier application number: M020
GlowBiotics Tinted Sunscreen SPF 30	ZINC OXIDE	Rum Brands, LLC	544dba29-4785-4ab6-e063-6394a90a17b3	2026-06-16	Warnings	Exact identifier application number: M020
Societe Prime and Defend	ZINC OXIDE SUNSCREEN	Societe Clinical Skincare	5439bd31-5ee1-9bca-e063-6394a90a748c	2026-06-16	Warnings	Exact identifier application number: M020
Societe CoverShield Tinted SPF	ZINC OXIDE	Societe Clinical Skincare	545efbc4-82d4-f126-e063-6294a90a9710	2026-06-16	Warnings	Exact identifier application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREEN	ZINC OXIDE	Moes Group LLC	546b0702-a3cc-fd6f-e063-6394a90af849	2026-06-16	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30	ZINC OXIDE	Whole Foods Market, Inc.	5ce712d6-cafd-4a80-9f8c-2149fdebff54	2026-06-16	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50	ZINC OXIDE	Whole Foods Market, Inc.	1f8387be-d871-435b-baef-e537c67a510a	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATE	Whole Foods Market, Inc.	82771f22-0197-40ba-97d2-2386152790ed	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Whole Foods Market, Inc.	1c31f466-6a0d-46ce-9346-d2a0eb46c8d0	2026-06-15	Warnings	Exact identifier application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier application number: M020
Solvyn Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin LLC	b0a8d028-87d2-4339-8879-c62cbf8415f2	2026-06-15	Warnings	Exact identifier application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin, LLC	112364cd-a445-46c2-b2f3-f9705d682cf6	2026-06-15	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