Flawless by Sonya Aloe BB Creme

Product NDC: 11697-372
11-digit product format: 116970372
Labeler code: 11697
Product ID: 11697-372_93e8ed77-99db-4326-9e75-2c1b6a71aa89
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Aloe Vera of America, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE
Active strength: 3 g/45g
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	11697-372		I	Inactivated by FDA		2026-08-11
excluded package	package	11697-372	11697-372-02	I	Inactivated by FDA		2026-08-11

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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	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	11697-372-02	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11697-372-02	2020-01-31	C162847	48780-1	9d75b9d0-857e-f424-e053-dadaa90a57ce	e2bd982e-3e5b-4857-9af0-087abe92de9f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11697-372-01	Flawless by Sonya Aloe BB CremeSandy	45 g in 1 TUBE	CREAM	45		3
11697-372-02	Flawless by Sonya Aloe BB CremeSandy	1 in 1 CARTON	CREAM	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
ACMELLA OLERACEA FLOWER	INACTIVE INGREDIENT	2794N5KM0K	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
BLACK OLIVE	INACTIVE INGREDIENT	2M6QWV94OC	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)	INACTIVE INGREDIENT	G300307ZXP	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
COCO-CAPRYLATE	INACTIVE INGREDIENT	4828G836N6	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	INACTIVE INGREDIENT	9E4CO0W6C5	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE	INACTIVE INGREDIENT	3Y9NJ5Z7E5	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
MICA	INACTIVE INGREDIENT	V8A1AW0880	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
OLEA EUROPAEA LEAF	INACTIVE INGREDIENT	MJ95C3OH47	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
STEARALKONIUM HECTORITE	INACTIVE INGREDIENT	OLX698AH5P	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
TRISODIUM ETHYLENEDIAMINE DISUCCINATE	INACTIVE INGREDIENT	YA22H34H9Q	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
TROPOLONE	INACTIVE INGREDIENT	7L6DL16P1T	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11697-372	FLAWLESS BY SONYA ALOE BB CREME SANDY (TITANIUM DIOXIDE) CREAM [ALOE VERA OF AMERICA, INC.]	3	Legacy NDC, 2 package rows	20150125_e2bd982e-3e5b-4857-9af0-087abe92de9f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
11697-372-01	11697037201	45 g in 1 TUBE	45 g	Historical
11697-372-02	11697037202	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flawless by Sonya Aloe BB Creme Sandy - Aloe Vera of America, Inc.	Aloe Vera of America, Inc.	2015-01-22	HUMAN OTC DRUG LABEL	3