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 24 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE L'Oreal USA Products Inc 79fd34ad-cd4a-4fa0-9b7c-e0a2252654da 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE SICOS ET CIE 3ff286c0-4515-4cab-9b93-a782545b2f36 2026-05-27 Warnings Exact identifier application number: M020 MyDerm SPF 50 HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00% Inspec Solutions LLC 1a995cda-dc67-419c-90e6-c61050c76098 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 2b634b3f-0d2b-4ae4-b302-9befb14a90df 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE fce593a2-f4ed-46c1-81a1-be3941649e47 2026-05-27 Warnings Exact identifier application number: M020 BROTEGE Good Boy Protection SPF 15 and Retinol Daily Moisturizer BENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE Spa de Soleil 1f47e508-58dd-fab4-e063-6394a90a668a 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Waterful SunLotion Mild SPF 40 ZINC OXIDE Zero to Seven Inc. 1e86edfd-d089-ba41-e063-6294a90a6709 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Baby Easy Wash SunLotion SPF 30 ZINC OXIDE Zero to Seven Inc. 1e86c2a9-a5c3-95cb-e063-6394a90a014d 2026-05-27 Warnings Exact identifier application number: M020 Stream2Sea Reef Safer Mineral Sunscreen SPF40 ZINC OXIDE Stream2Sea, LLC 52e73c23-75ec-d8a8-e063-6294a90a5493 2026-05-27 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Rosewood ZINC OXIDE Riversol 52b8f588-8383-634e-e063-6294a90a8f8b 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Poppy ZINC OXIDE Riversol 52b92725-6d9a-768a-e063-6394a90ac933 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - Jazzy Berry ZINC OXIDE Odacite 52b97fb0-84d6-a408-e063-6294a90a9be9 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - True Nude ZINC OXIDE Odacite 52b9be2a-4958-f537-e063-6294a90a7a1b 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Poppy ZINC OXIDE Solesence, Inc. 52ba09cb-edcc-a405-e063-6394a90a6aab 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - Bubble Gum ZINC OXIDE Odacite 52b9fb0a-0554-0de2-e063-6294a90a09d3 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Rosewood ZINC OXIDE Solesence, Inc. 52ba07f1-b74e-a4b6-e063-6394a90a7473 2026-05-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 50 Sunscreen ZINC OXIDE SKIN DAMAGE INC. 52ba2f12-839f-cea1-e063-6394a90a5ae6 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Bronze Jolie ZINC OXIDE Odacite 52ba360e-375c-0469-e063-6294a90a020e 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Golden Hour ZINC OXIDE Odacite 52ba8e03-1944-b73d-e063-6294a90a5039 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Sienna Rose ZINC OXIDE Odacite 52ba7f12-2b79-79cf-e063-6294a90a92d8 2026-05-26 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