Sunkiss

Product NDC: 41442-133
11-digit product format: 414420133
Labeler code: 41442
Product ID: 41442-133_99c23df0-8293-412b-b9a6-3b72fadc024a
Type: HUMAN OTC DRUG
Nonproprietary name: titanium dioxide and zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Omorovicza Kozmetikai Kft
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-05-06
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 1 mL/50mL; mL/50mL
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41442-133		I	Inactivated by FDA		2026-10-16
excluded package	package	41442-133	41442-133-01	I	Inactivated by FDA		2026-10-16

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41442-133-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41442-133-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41442-133-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41442-133-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41442-133-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41442-133-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41442-133-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41442-133-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41442-133-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41442-133-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41442-133-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41442-133-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	41442-133-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	41442-133-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	41442-133-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	41442-133-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	41442-133-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	41442-133-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	41442-133-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41442-133-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	41442-133-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	41442-133-01	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
41442-133-01	2019-10-29	C162847	48780-1	960f7f55-c6d7-8e05-e053-dbdaa90a074a	SUNKISS SPF 15 NAPVARÁZS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41442-133-01	Sunkiss SPF15	1 in 1 BOX	CREAM	1		1
41442-133-01	Sunkiss SPF15	50 mL in 1 BOTTLE, GLASS	CREAM	50		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
zinc oxide	ACTIVE INGREDIENT	SOI2LOH54Z	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
zinc oxide	ACTIVE MOIETY	SOI2LOH54Z	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
.BETA.-CITRONELLOL, (R)-	INACTIVE INGREDIENT	P01OUT964K	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
acerola	INACTIVE INGREDIENT	XDD2WEC9L5	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
alpha-tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
apple	INACTIVE INGREDIENT	B423VGH5S9	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
APRICOT KERNEL OIL	INACTIVE INGREDIENT	54JB35T06A	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
geraniol	INACTIVE INGREDIENT	L837108USY	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
HYDROXYSTEARIC ACID	INACTIVE INGREDIENT	933ANU3H2S	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
isostearic acid	INACTIVE INGREDIENT	X33R8U0062	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
linalool, dl-	INACTIVE INGREDIENT	D81QY6I88E	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
mica	INACTIVE INGREDIENT	V8A1AW0880	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
pectin	INACTIVE INGREDIENT	89NA02M4RX	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
sorbitan olivate	INACTIVE INGREDIENT	MDL271E3GR	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
squalane	INACTIVE INGREDIENT	GW89575KF9	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
STEARYL ETHYLHEXANOATE	INACTIVE INGREDIENT	X8707A2274	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41442-133	SUNKISS (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT]	1	Legacy NDC, 2 package rows	20110510_5523eaee-0879-4932-85e3-bd878d1498f6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
41442-133-01	41442013301	1 in 1 BOX	Historical