OIL CONTROLLING MAKEUP

Product NDC: 68828-046
11-digit product format: 688280046
Labeler code: 68828
Product ID: 68828-046_540c038c-5736-4ce9-a4d6-cda4623d1444
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE OCTISALATE OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: JAFRA COSMETICS INTERNATIONAL
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-04-19
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 6 g/100mL; g/100mL; g/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
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	68828-046		I	Inactivated by FDA		2026-10-05
excluded package	package	68828-046	68828-046-67	I	Inactivated by FDA		2026-10-05

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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68828-046-67	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68828-046-67	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68828-046-67	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68828-046-67	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68828-046-67	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68828-046-67	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68828-046-67	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68828-046-67	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68828-046-67	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68828-046-67	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68828-046-67	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68828-046-67	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68828-046-67	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68828-046-67	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68828-046-67	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68828-046-67	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68828-046-67	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68828-046-67	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68828-046-67	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68828-046-67	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68828-046-67	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68828-046-67	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
68828-046-67	2020-01-31	C162847	48780-1	9d75b9d0-9835-f424-e053-dadaa90a57ce	OIL CONTROLLING MAKEUP SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68828-046-11	OIL CONTROLLING MAKEUPSPF 15	30 mL in 1 BOTTLE	LOTION	30		1
68828-046-67	OIL CONTROLLING MAKEUPSPF 15	1 in 1 BOX	LOTION	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ALTHAEA OFFICINALIS ROOT	INACTIVE INGREDIENT	TRW2FUF47H	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)	INACTIVE INGREDIENT	59TL3WG5CO	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
DI-PPG-3 MYRISTYL ETHER ADIPATE	INACTIVE INGREDIENT	T32481VTXW	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
HAMAMELIS VIRGINIANA BARK	INACTIVE INGREDIENT	IH3063S9MY	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
IPOMOEA MAURITIANA TUBER	INACTIVE INGREDIENT	K67Y2SGX79	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ISOPROPYL ISOSTEARATE	INACTIVE INGREDIENT	C67IXB9Y7T	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
LAURETH-12	INACTIVE INGREDIENT	OAH19558U1	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
MUNG BEAN	INACTIVE INGREDIENT	1LIB31N73G	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
PEG-4 LAURATE	INACTIVE INGREDIENT	AYF4VM3N1Z	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
POLYSILICONE-15	INACTIVE INGREDIENT	F8DRP5BB29	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
TRIHYDROXYSTEARIN	INACTIVE INGREDIENT	06YD7896S3	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
WITHANIA SOMNIFERA FLOWER	INACTIVE INGREDIENT	2HZ95R7082	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68828-046	OIL CONTROLLING MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1	Legacy NDC, 2 package rows	20120501_63592ad9-283f-46bb-9837-b72a53159cbb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68828-046-11	68828004611	30 mL in 1 BOTTLE	30 ml	Historical
68828-046-67	68828004667	1 in 1 BOX		Historical