Home NDC 10348-004 smashbox
Product NDC 10348-004
11-digit product format 103480004
Labeler code 10348
Product ID 10348-004_914e2639-b8ad-40a3-9843-035cfab7f440
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE and OCTISALATE
Dosage form LOTION
Route TOPICAL
Labeler SMASHBOX BEAUTY COSMETICS, INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-10-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE
Active strength 8 mL/100mL; mL/100mL
NDC exclude flag E
Listing certified through 2018-12-31
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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 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 10348-004-01 smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER 1 in 1 CARTON LOTION 1 1 10348-004-01 smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER 30 mL in 1 TUBE LOTION 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Alkyl (C12-15) Benzoate INACTIVE INGREDIENT A9EJ3J61HQ SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Alpha-Tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Camellia Oleifera Leaf INACTIVE INGREDIENT 5077EL0C60 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Caprylyl Glycol INACTIVE INGREDIENT 00YIU5438U SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Ceramide 2 INACTIVE INGREDIENT C04977SRJ5 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Cola Acuminata Seed INACTIVE INGREDIENT 1F8VIW1479 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Diethylamino Hydroxybenzoyl Hexyl Benzoate INACTIVE INGREDIENT ANQ870JD20 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Ethylhexylglycerin INACTIVE INGREDIENT 147D247K3P SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Hexylene Glycol INACTIVE INGREDIENT KEH0A3F75J SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Palmitoyl Oligopeptide INACTIVE INGREDIENT HO4ZT5S86C SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 PEG-10 Rapeseed Sterol INACTIVE INGREDIENT 258O76T85M SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Safflower Oil INACTIVE INGREDIENT 65UEH262IS SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Tribehenin INACTIVE INGREDIENT 8OC9U7TQZ0 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Triethoxycaprylylsilane INACTIVE INGREDIENT LDC331P08E SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Vitamin A Palmitate INACTIVE INGREDIENT 1D1K0N0VVC SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Vitis Vinifera Seed INACTIVE INGREDIENT C34U15ICXA SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Water INACTIVE INGREDIENT 059QF0KO0R SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10348-004 SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC] 1 Legacy NDC, 2 package rows 20120126_afb9b34d-3107-45e2-ba68-9a991c09e622.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10348-004-01 10348000401 1 in 1 CARTON Historical