Sunscreen

Product NDC: 55910-012
11-digit product format: 559100012
Labeler code: 55910
Product ID: 55910-012_4c10c12b-2e1f-8b32-e063-6294a90a18e9
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate,Otisalate, Octocrylene
Dosage form: SPRAY
Route: TOPICAL
Labeler: Old East Main Co.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-01
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55910-012	55910-012-15	D	Discontinued by firm		2026-10-20

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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
AVOBENZONE	30 mg/g
HOMOSALATE	150 mg/g
OCTISALATE	50 mg/g
OCTOCRYLENE	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
2ea288fe-815d-4568-9592-55ea428448fa	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55910-012-14	Sunscreen	156 g in 1 CAN	SPRAY	156	20
55910-012-15	Sunscreen	258 g in 1 CAN	SPRAY	258	20
55910-012-39	Sunscreen	312 g in 1 CAN	SPRAY	312	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-012	SUNSCREEN (AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE) SPRAY [OLD EAST MAIN CO]	18	Current NDC, Legacy NDC, 3 package rows	20241013_2ea288fe-815d-4568-9592-55ea428448fa.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 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	08f4599b-de62-2bc7-e063-6394a90a69ab	2025-12-31	Warnings	Exact identifier application number: M020
Hawaiian Tropic Everyday Active SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc8e2ee8-e67f-ef5d-e053-2995a90a1520	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Glowing, SPF 30	SUNSCREEN GLOWING LOTION	Cardinal Health, Inc	28ed3b60-1139-f657-e063-6394a90a52fa	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	Cardinal Health, inc.	293e9656-8644-b9aa-e063-6294a90a5b27	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	FSA Store Inc	473d6804-8d20-6899-e063-6294a90a3131	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47428cd4-fbad-ba7a-e063-6394a90a1c5c	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47433a62-91e0-b031-e063-6294a90a0d49	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4743b6a9-4d79-1b2b-e063-6394a90a9710	2025-12-31	Warnings	Exact identifier application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 Earth	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0edc7bd4-9350-48e1-bbfe-e6450458ae59	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bronze	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	90fbf555-106c-4131-b572-ead9bbb246e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Honey	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1accbe67-c722-4af7-8422-0559ac4a987a	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bare	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5c0805c7-9b92-4c08-877c-64e720308430	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20- Natural	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0cc5429d-ace4-4060-b993-1b607218eaf8	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20-Nude	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	b1851c5d-32ad-482a-bd24-2f280a68ef9e	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 -Spice	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6164dc23-81c2-48b8-b309-2c5a81fe13a4	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Tawny	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Cappuccino	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	30601a73-089e-4fa7-8fb7-6b108498934a	2025-12-31	Warnings	Exact identifier application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30	ZINC OXIDE SUNSCREEN	SOLARA SUNCARE, INC.	209c4913-29e6-24ca-e063-6294a90a6872	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-012-14	55910001214	156 g in 1 CAN (55910-012-14)	156 g	2019-10-01	0000-00-00	No	No	Current
55910-012-15	55910001215	258 g in 1 CAN (55910-012-15)	258 g	2019-10-01	0000-00-00	No	No	Current
55910-012-39	55910001239	312 g in 1 CAN (55910-012-39)	312 g	2019-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Studio Selection 958.000/958AA Sport Sunscreen Spray SPF 70	Old East Main Co. \| Nice-Pak Products, LLC	2026-03-02	HUMAN OTC DRUG LABEL	20