Home NDC 11697-319 Aloe Sunscreen
Product NDC 11697-319
11-digit product format 116970319
Labeler code 11697
Product ID 11697-319_50c98089-b653-428f-bb12-5cd65b50b9a8
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Avobenzone, Ensulizole anf Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Aloe Vera of America, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-08-16
Marketing end 0000-00-00
Substance HOMOSALATE; OCTISALATE; ENSULIZOLE; AVOBENZONE; OCTOCRYLENE
Active strength 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 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 11697-319-07 Aloe Sunscreen 178.000 mL in 1 BOTTLE, SPRAY SPRAY 178.000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 ENSULIZOLE ACTIVE INGREDIENT 9YQ9DI1W42 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 AVOBENZONE ACTIVE MOIETY G63QQF2NOX ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 ENSULIZOLE ACTIVE MOIETY 9YQ9DI1W42 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 HOMOSALATE ACTIVE MOIETY V06SV4M95S ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 OCTISALATE ACTIVE MOIETY 4X49Y0596W ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 BUTYLOCTYL SALICYLATE INACTIVE INGREDIENT 2EH13UN8D3 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 CETEARETH-25 INACTIVE INGREDIENT 8FA93U5T67 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 DIETHYLHEXYL CARBONATE INACTIVE INGREDIENT YCD50O0Z6L ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE INACTIVE INGREDIENT QI9A6U005W ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 NEOPENTYL GLYCOL DIHEPTANOATE INACTIVE INGREDIENT 5LKW3C543X ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 PENTYLENE GLYCOL INACTIVE INGREDIENT 50C1307PZG ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 POLYESTER-7 INACTIVE INGREDIENT 0841698D2F ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) INACTIVE INGREDIENT 5Z4DPO246A ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 WATER INACTIVE INGREDIENT 059QF0KO0R ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11697-319 ALOE SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE ANF OCTOCRYLENE) SPRAY [ALOE VERA OF AMERICA, INC.] 13 Legacy NDC, 1 package rows 20150130_d1fc6718-8611-44b5-b312-8cf4866cb46b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 11697-319-07 11697031907 178.000 mL in 1 BOTTLE, SPRAY 178.000 ml Historical