ELF Broad Spectrum SPF 20 Sunscreen Buff BB Cream

Product NDC: 76354-610
Requested package NDC: 76354-610-01
11-digit product format: 763540610
Labeler code: 76354
Product ID: 76354-610_6092ecb0-954d-4705-aac5-d99b875ca8eb
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE
Dosage form: CREAM
Route: TOPICAL
Labeler: J. A. Cosmetics U.S. INC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-10-10
Marketing end: 0000-00-00
Substance: OCTINOXATE; OXYBENZONE; OCTISALATE
Active strength: 8 g/100mL; g/100mL; g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	76354-610	76354-610-01	I	Inactivated by FDA		2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
76354-610-01	2023-01-30	C162847	48780-1	9d75b9d0-7af5-f424-e053-dadaa90a57ce	Drug Fact
76354-610-01	2020-02-26	C162847	48780-1	9d75b9d0-7af5-f424-e053-dadaa90a57ce	Drug Fact
76354-610-01	2020-01-31	C162847	48780-1	9d75b9d0-7af5-f424-e053-dadaa90a57ce	Drug Fact

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76354-610-01	ELF Broad Spectrum SPF 20 Sunscreen Buff BB Cream	28.5 mL in 1 BOTTLE	CREAM	28.5		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
ALOE ANDONGENSIS LEAF	INACTIVE INGREDIENT	N1P4NU25EJ	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
CUCUMBER FRUIT OIL	INACTIVE INGREDIENT	R81Y52NPCT	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
QUATERNIUM-18	INACTIVE INGREDIENT	O7757NO1VL	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
SODIUM CHLORATE	INACTIVE INGREDIENT	T95DR77GMR	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76354-610	ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]	2	Legacy NDC, 1 package rows	20200227_3d816571-a9b4-491e-8650-3def890fb273.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76354-610-01	76354061001	28.5 mL in 1 BOTTLE (76354-610-01)	28.5 ml	2015-10-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Fact	J. A. Cosmetics U.S. INC \| Hangzhou Facecare Cosmetics Co., Ltd. \| Columbia Cosmetics Manufacturing, Inc.	2015-10-17	HUMAN OTC DRUG LABEL	2