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 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 314 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 83725be5-4a0a-4717-a034-ff2999dd4099 2023-12-16 Warnings Exact identifier application number: M020 Light Day Sunscreen SPF 37 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Circadia by Dr Pugliese, Inc. 16d76785-22a0-4a4b-a6f1-74056612e936 2023-12-15 Warnings Exact identifier application number: M020 ERBORIAN - BB CREME NUDE SPF20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 337a771e-c965-421a-a8e7-d853ffe51c2c 2023-12-15 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium TITANIUM DIOXIDE AND ZINC OXIDE Cosmetique Active Production b4cef09a-f0e4-4054-a200-667df7d150bf 2023-12-15 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 1f3b56d5-c33a-401f-8c8a-924345a4846e 2023-12-15 Warnings Exact identifier application number: M020 Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE Isagenix International, LLC 6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce 2023-12-14 Warnings Exact identifier application number: M020 bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01 TITANIUM DIOXIDE Orveon Global US LLC 29738578-6681-476e-8660-7219f58e8fa0 2023-12-13 Warnings Exact identifier application number: M020 Sheer Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Allure Labs 0c6ac094-cb5b-0f09-e063-6394a90a9eed 2023-12-13 Warnings Exact identifier application number: M020 REDEFINE Triple Defense AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Rodan & Fields ed0209a6-a8ce-4394-bcf0-32d585a6b834 2023-12-13 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Cosmetique Active Production 4e56f3f2-b856-4bbc-ab39-6fb5887a4846 2023-12-13 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 2ce83dc2-84b6-43fd-8b11-495d41cebc22 2023-12-13 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE Cosmetique Active Production 4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca 2023-12-13 Warnings Exact identifier application number: M020 6000X Elemental Screen BS SPF 30 Sunscreen ZINC OXIDE Allure Labs 0c574a9a-edea-d333-e063-6394a90a41e3 2023-12-12 Warnings Exact identifier application number: M020 RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE Rodan & Fields 1a936053-2be0-4c52-a073-ba846b87f811 2023-12-12 Warnings Exact identifier application number: M020 Beet the sun lightweight sunscreen broad spectrum spf 40 pa AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Krave Beauty, LLC ff93d086-ec80-6bd5-e053-6294a90af019 2023-12-12 Warnings Exact identifier application number: M020 Broad Spectrum SPF 30 Up The Anti TITANIUM DIOXIDE, ZINC OXIDE Biopelle, Inc. 37506766-370e-4ae4-8dbe-915a763e7c55 2023-12-12 Warnings Exact identifier application number: M020 INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE DermStore, LLC 19640e0c-c6b3-43b8-91e9-d8d9fff2e44e 2023-12-12 Warnings Exact identifier application number: M020 Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen ZINC OXIDE Englewood Lab, Inc. 273d8e30-a6bc-4b26-919c-9332fd5197fa 2023-12-12 Warnings Exact identifier application number: M020 Youth Activating BB SPF30 Shade 3 ZINC OXIDE, TITANIUM DIOXIDE Englewood Lab, Inc. c84207c4-a779-4c00-a486-86eaf8ece169 2023-12-12 Warnings Exact identifier application number: M020 Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Rodan & Fields c7526b69-d059-499a-9134-3a1f5d0471b3 2023-12-12 Warnings 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