Home NDC 11697-372 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
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# 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 Uploaded 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
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