SPF-15 Sunscreen

Product NDC
49794-048
11-digit product format
497940048
Labeler code
49794
Product ID
49794-048_3110ce92-5a57-4dd5-84a0-aebaa5f0678a
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Continental Manufacturing Chemist, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-16
Marketing end
0000-00-00
Substance
OCTOCRYLENE; AVOBENZONE
Active strength
100 g/L; g/L
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49794-048IInactivated by FDA2026-10-05
excluded packagepackage49794-04849794-048-99IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49794-048-99d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49794-048-99f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49794-048-992ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49794-048-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49794-048-99cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49794-048-99cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49794-048-99302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49794-048-99ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49794-048-990efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49794-048-99ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49794-048-99367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49794-048-99557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49794-048-998af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49794-048-99834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49794-048-991332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49794-048-99fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49794-048-9986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49794-048-99bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49794-048-998dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49794-048-99e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49794-048-999bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49794-048-99110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49794-048-992019-11-13C16284748780-197449f38-d550-f6ea-e053-dbdaa90aa703Broad-Spectrum SPF-15 Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49794-048-99SPF-15 Sunscreen1100 L in 1 CONTAINERLOTION11004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
AVOBENZONEACTIVE MOIETYG63QQF2NOXSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ESPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)INACTIVE INGREDIENT5F4963KLHSSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49794-048SPF-15 SUNSCREEN (OCTOCRYLENE, AVOBENZONE) LOTION [CONTINENTAL MANUFACTURING CHEMIST, INC.]4Legacy NDC, 1 package rows20120720_b3ea0417-65c2-46ca-9c52-31376dd85637.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49794-048-99497940048991100 L in 1 CONTAINER1100 lHistorical