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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55550-102-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55550-102-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55550-102-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55550-102-018dfbde2a14a4…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
IngredientStrength
HOMOSALATE6 mg/g
OCTINOXATE7.5 mg/g
OCTISALATE5 mg/g
OXYBENZONE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d4f820d-e154-428e-89c2-2e26e088ceefAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-102-012023-01-26C16284748780-1ba0f9c33-2171-a910-e053-dadaa90a0b85Sunscreen
55550-102-012021-01-29C16284748780-1ba0f9c33-2171-a910-e053-dadaa90a0b85Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-102-01Sunscreen1.5 g in 1 PACKETLOTION1.54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95SSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OctisalateACTIVE INGREDIENT4X49Y0596WSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
HomosalateACTIVE MOIETYV06SV4M95SSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OctinoxateACTIVE MOIETY4Y5P7MUD51SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OctisalateACTIVE MOIETY4X49Y0596WSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
OxybenzoneACTIVE MOIETY95OOS7VE0YSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
edetate sodiumINACTIVE INGREDIENTMP1J8420LUSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9ISUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
povidone K30INACTIVE INGREDIENTU725QWY32XSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
waterINACTIVE INGREDIENT059QF0KO0RSUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEESUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-102SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [TOTAL RESOURCES INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20241228_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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55550-102-01555500102011.5 g in 1 PACKET (55550-102-01) 1.5 g2023-01-20NoNoCurrent