SolScents

Product NDC
58443-0175
11-digit product format
584430175
Labeler code
58443
Product ID
58443-0175_9c5a8513-5513-7c43-e053-2a95a90a6c14
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
77 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct58443-0175IInactivated by FDA2026-10-16
excluded packagepackage58443-017558443-0175-3IInactivated by FDA2026-10-16

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 · 30 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 packagepackage58443-0175-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58443-0175-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58443-0175-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58443-0175-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58443-0175-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58443-0175-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58443-0175-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58443-0175-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58443-0175-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58443-0175-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58443-0175-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58443-0175-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58443-0175-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58443-0175-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58443-0175-31332a3947898…d4bfe170f9cd…

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
58443-0175-32024-01-30C16284748780-11030e365-58f7-111a-e063-dadaa90a10e2e5201105-75c4-496d-b1cb-d6d01e280455

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0175-3SolScentsClear Face Flower Blast Broad Spectrum spf 50100 mL in 1 BOTTLELOTION1003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ISOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)INACTIVE INGREDIENT5F4963KLHSSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SODIUM COCOYL GLUTAMATEINACTIVE INGREDIENTBMT4RCZ3HGSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
SUNFLOWER SEED OIL GLYCERETH-8 ESTERSINACTIVE INGREDIENT358X17CAT0SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
TRIDECETH-6INACTIVE INGREDIENT3T5PCR2H0CSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0175SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50 (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]3Legacy NDC, 1 package rows20200118_e5201105-75c4-496d-b1cb-d6d01e280455.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0175-358443017503100 mL in 1 BOTTLE (58443-0175-3) 100 ml2015-04-010000-00-00NoNoCurrent