Home NDC 49358-601 Hydrating Sheer Lip Balm SPF 30 - BARE
Product NDC 49358-601
11-digit product format 493580601
Labeler code 49358
Product ID 49358-601_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 49358-601-01 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 49358-601-01 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 49358-601-01 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 49358-601-01 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 49358-601-01 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 49358-601-01 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 49358-601-01 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 - BARE
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 49358-601-01 Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen 1 in 1 CARTON LIPSTICK 1 2 49358-601-01 Hydrating Sheer Lip Balm SPF 30 - BAREBroad 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 49358-601 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 223 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e24391f-4982-efae-e063-6394a90accaa 2025-03-01 Warnings Exact identifier application number: M020 FRUDIA Blueberry Hydrating Air Fit Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WELCOS CO.,LTD. 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b 2025-02-28 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL ZINC OXIDE SPF Ventures, LLC 2f1b5454-8bf5-b447-e063-6394a90a743a 2025-02-27 Warnings Exact identifier application number: M020 Clear Defense SPF 45 ZINC OXIDE, OCTINOXATE Private Label Skin Care d681d92f-3501-4fca-b629-096341f20ab1 2025-02-27 Warnings Exact identifier application number: M020 HA Physical Tint SPF 44 ZINC OXIDE, TITANIUM DIOXIDE Private Label Skin Care a5e19d77-703e-41e0-9a02-19227dc6c819 2025-02-27 Warnings Exact identifier application number: M020 Physical Daily Defense Broad Spectrum Sunscreen SPF 40 ZINC OXIDE Private Label Skin Care 18444581-66a4-4eda-a8df-627fa3b4b98a 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 2f069114-9ca8-aed4-e063-6394a90a46d8 2025-02-26 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N Melaleuca Inc. 2f133abb-cad2-2ac8-e063-6294a90aa480 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 KIDS MINERAL ZINC OXIDE SPF Ventures, LLC 2f17b5fe-44da-964b-e063-6394a90ae699 2025-02-26 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2efb73a6-601d-61a4-e063-6294a90af825 2025-02-25 Warnings Exact identifier application number: M020 Rida Hair Research Institute AVOBENZONE,OCTISALATE,OCTOCRYLENE Rida LLC ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 70 Peach Blossom AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed217698-f552-677e-e053-2995a90acb0a 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Tropical Coconut AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed0f8249-aba8-b67c-e053-2a95a90af7eb 2025-02-25 Warnings Exact identifier application number: M020 Hydro Essence Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, OCTINOXATE Private Label Skin Care f176c1b1-f539-417f-98b5-69d99365f2f2 2025-02-25 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2ee82379-6609-fd8e-e063-6294a90acf6c 2025-02-24 Warnings Exact identifier application number: M020 Vacation SPF 50 Classic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f2780cb5-063c-10d3-e053-2995a90a8576 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2ee9b3dc-91cd-1af9-e063-6394a90a78e1 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2edc79f8-aac5-15eb-e063-6394a90a9736 2025-02-23 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc25651b-0e30-c325-e053-2995a90a809e 2025-02-21 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc129cd6-a173-d2b3-e053-2a95a90aa04e 2025-02-21 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 49358-601-01 49358060101 1 APPLICATOR in 1 CARTON (49358-601-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current