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 133 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenishing Daily Protection ZINC OXIDE The Maui Medical Group, Inc 34b96d82-7fcf-e452-e063-6394a90a781b 2025-12-11 Exact identifier application number: M020 Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY LLC 3750c2fd-c5cc-fd00-e063-6394a90aeb89 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 3750ffbf-a82d-b4b9-e063-6294a90a7d68 2025-12-11 Exact identifier application number: M020 The Block ZINC OXIDE ELITE ESTHETICS BY NICOLE CAROLINE LLC 34a6b17e-6e9e-3f2c-e063-6294a90a1c32 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum Non-Tinted ZINC OXIDE Teton Dermatology Holdings, Inc. 35093797-008b-b265-e063-6294a90a9949 2025-12-11 Exact identifier application number: M020 Tinted Zinc Protection ZINC OXIDE Teton Dermatology Holdings, Inc. 3508d5a8-9d3c-51d1-e063-6394a90abc8e 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 35081ce0-2203-ab86-e063-6294a90aefd5 2025-12-11 Exact identifier application number: M020 Antioxidant SPF ZINC OXIDE Teton Dermatology Holdings, Inc. 3509a916-f3e1-9c53-e063-6394a90a5bff 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen Tinted ZINC OXIDE HALEM DERMATOLOGY PLLC 35bb4953-ca8c-e927-e063-6394a90a1a31 2025-12-11 Exact identifier application number: M020 Lip Protection TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 3509eea7-f966-2080-e063-6294a90aeeb5 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HALEM DERMATOLOGY PLLC 35bce44e-d9f4-9279-e063-6394a90a6453 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35bc5ff5-8eb8-54cf-e063-6394a90ae3c2 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350ad191-e51c-083d-e063-6394a90aa646 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen ZINC OXIDE HALEM DERMATOLOGY PLLC 35be5dc0-861f-3738-e063-6394a90a23ca 2025-12-11 Exact identifier application number: M020 Tinted Mineral Daily Sunscreen TITANIUM DIOXIDE ,ZINC OXIDE Jordan Macall Acne & Anti-Aging Skincare LLC 350b2246-6e00-38fc-e063-6294a90ae382 2025-12-11 Exact identifier application number: M020 Calming Protection SPF40 ZINC OXIDE FRESH FACED SKIN CARE LLC 35d0c081-67b4-ce46-e063-6294a90ad822 2025-12-11 Exact identifier application number: M020 Tinted Facial Protection SPF40 TITANIUM DIOXIDE, ZINC OXIDE FRESH FACED SKIN CARE LLC 35d08e2a-b118-8634-e063-6294a90a918d 2025-12-11 Exact identifier application number: M020 Total Body Block Sunscreen ZINC OXIDE THE COMPLEXIONIST 38f53f6a-8e68-e30f-e063-6394a90afef2 2025-12-11 Exact identifier application number: M020 Fair Skin Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351bb329-90ea-f19a-e063-6394a90af107 2025-12-11 Exact identifier application number: M020 Oil Free Anti-Aging ZINC OXIDE DERMOPERFECTION SKINCARE SERVICES, LLC 351b4870-d9bd-c356-e063-6394a90a7763 2025-12-11 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