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 72 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE AVON COMPANY	48e8b7f5-6977-bfae-e063-6394a90a888b	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	32725ca7-ec21-4643-bdc6-278fd647b95d	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	e6877f7a-3aaa-4096-bcb5-eae0aa2532e5	2026-01-21	Warnings	Exact identifier application number: M020
MINICELL UV SHIELD SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CELINA CO., LTD.	48eff8fa-deec-a434-e063-6294a90aa861	2026-01-21	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 30	ZINC OXIDE	Delta Ecommerce LLC	47dbcf07-7e3a-e3de-e063-6294a90a2c21	2026-01-21	Warnings	Exact identifier application number: M020
sunscreen	TITANIUM DIOXIDE	Guangdong Zhoubang Biotechnology Co., Ltd	48f13b1c-8104-881b-e063-6394a90a816d	2026-01-21	Warnings	Exact identifier application number: M020
Sunscreen lip balm	ETHYLHEXYL SALICYLATE	Guangdong Zhoubang Biotechnology Co., Ltd	48f1ee5c-33d0-818c-e063-6294a90a1e59	2026-01-21	Warnings	Exact identifier application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Mother	CEILE SPF 30 PRIME PROTECT RADIATE MOTHER	LE COSMETICS INC	490db6ef-d7f2-446c-e063-6294a90af303	2026-01-21	Warnings	Exact identifier application number: M020
DewyVita Zero Spot Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	BAREUNPLAN CO.,LTD.	497c98c3-d809-52e0-e063-6294a90acca2	2026-01-21	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	OCTINOXATE, OXYBENZONE, AVOBENZONE	Bentley Laboratories LLC	4c0b4733-96ea-4b1d-8a7b-13af66cc28d0	2026-01-21	Warnings	Exact identifier application number: M020
Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	RV Skincare LLC	86b46c9b-6573-439b-b38b-2d76d495df6d	2026-01-20	Warnings	Exact identifier application number: M020
Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	RV Skincare LLC	1b8cf189-0d06-4e86-bd7b-b77a638f1670	2026-01-20	Warnings	Exact identifier application number: M020
Bella s Friends SPF50 Sunscreen	ZINC OXIDE	PANERGYTEKUSAINC	48ce4ef7-e24a-4894-e063-6294a90a49c8	2026-01-20	Warnings	Exact identifier application number: M020
Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	93a27f09-14e2-47a0-ac5f-4d3425e31ec9	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	d00b978d-1682-4cde-ae5f-189e677136c4	2026-01-20	Warnings	Exact identifier application number: M020
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer	ZINC OXIDE	Clean Beauty For All, Inc	b6bfd636-2f46-3fca-e053-2a95a90a05a6	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	19230647-29a3-d209-e063-6394a90aae36	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	8e2a2046-13e6-4a40-a0bc-65c979c59b93	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	dbc4242a-3651-48be-bfc6-c595be5a2a15	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922f11d-10ce-82b4-e063-6394a90a6650	2026-01-20	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