SUNZONE KIDS SPF 60

Product NDC
50021-061
11-digit product format
500210061
Labeler code
50021
Product ID
50021-061_a3e1687e-55ea-46bd-888b-76ae21b21dbb
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate.
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Empack Spraytech Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-11-16
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE
Active strength
8 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50021-061-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50021-061-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50021-061-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50021-061-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50021-061-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50021-061-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50021-061-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50021-061-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50021-061-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50021-061-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50021-061-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50021-061-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50021-061-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50021-061-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50021-061-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50021-061-01110d247fa046…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
50021-061-012019-11-27C16284748780-19855d018-d29b-cd31-e053-dbdaa90ab51aDRUG FACTS FOR SUNZONE KIDS SPF 60

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
HOMOSALATEACTIVE MOIETYV06SV4M95SSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTISALATEACTIVE MOIETY4X49Y0596WSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)INACTIVE INGREDIENTYP714N2H05SUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60SUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUNZONE KIDS SPF 60 BROAD SPECTRUM (OCTINOXATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE AND HOMOSALATE.) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]2