Home NDC 49358-604 Hydrating Sheer Lip Balm SPF 30 - SHIMMER
Product NDC 49358-604
11-digit product format 493580604
Labeler code 49358
Product ID 49358-604_36d8ea31-6d00-0d8f-e063-6394a90ae824
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, and Homosalate
Dosage form LIPSTICK
Route TOPICAL
Labeler MDSolarSciences
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength 30; 50; 100 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 14 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 2025-04-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49358-604-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49358-604-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49358-604-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrating Sheer Lip Balm SPF 30 - SHIMMER
Brand name suffix Broad Spectrum SPF 30 UVA-UVB Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g OCTISALATE 50 mg/g HOMOSALATE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup V06SV4M95S Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49358-604-01 Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen 1 in 1 CARTON LIPSTICK 1 2 49358-604-01 Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen 4.2 g in 1 APPLICATOR LIPSTICK 4.2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-604 HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES] 1 Current NDC, 2 package rows 20230922_0f23441c-2399-4a72-9f0a-420d25db78af.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 123 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 3724cb53-0198-c604-e063-6294a90aa64b 2025-12-15 Exact identifier application number: M020 Untinted Sheer Defense TITANIUM DIOXIDE, ZINC OXIDE Kristina Lerner 35be50b7-a9af-29ee-e063-6394a90a45ba 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 3724ea3c-b018-c125-e063-6394a90a01f1 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 37252429-d692-c05a-e063-6294a90a6af6 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d2fbeb-935b-f0a9-e063-6294a90acd79 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 423c7e62-ad50-0dc3-e063-6294a90ad05a 2025-12-15 Warnings Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 3699c107-d063-cc6f-e063-6394a90a6ad4 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 44776529-3aa6-4fa3-b2ce-f624c4cf41bd 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE JMSE Management, LLC 36ec860f-2066-196c-e063-6294a90a2121 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d3262a-1d8d-2afa-e063-6294a90afd49 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d37c2e-abc0-6bda-e063-6294a90a8fc3 2025-12-15 Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 36999510-88f0-64fc-e063-6294a90a3d09 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d3486c-c6e8-4d31-e063-6294a90a1219 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 3699f6df-63b8-f255-e063-6394a90af2c4 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 369a5997-7dbe-254d-e063-6394a90a5bef 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369a8a99-c755-3c7f-e063-6394a90ac16c 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369abc9d-9c20-5397-e063-6394a90a1723 2025-12-15 Exact identifier application number: M020 Sunshade Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37dec631-fdaf-fbdf-e063-6394a90a6c2b 2025-12-15 Exact identifier application number: M020 Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37527317-0f10-d7e6-e063-6394a90a35a6 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Stick Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee31be-bfda-f052-e063-6294a90ac0bb 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49358-604-01 49358060401 1 APPLICATOR in 1 CARTON (49358-604-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current