Soothing Day SPF 15

Product NDC
63550-192
Requested package NDC
63550-192-07
11-digit product format
635500192
Labeler code
63550
Product ID
63550-192_eecb2903-8256-a4e6-e053-2995a90aba16
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE OCTINOXATE OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Kamins Dermatologics Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-10-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength
20 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63550-19263550-192-07DDiscontinued by firm2026-10-05

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
ACER SACCHARUM SAPINACTIVE INGREDIENT75UOH57984SOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5PSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
CETETH-16INACTIVE INGREDIENT94826GMB5BSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
QUADROSILANINACTIVE INGREDIENTC5KT601WPMSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9SOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESOOTHING DAY SPF 15 (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63550-192-076355001920750 mL in 1 BOX (63550-192-07) 50 ml2010-10-010000-00-00NoNoCurrent