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 V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 176 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9d9419-a7e1-bc42-e063-6394a90af511 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e8af968-77d5-1dcd-e063-6394a90a6699 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9e95c3-4ac8-5962-e063-6294a90a0c02 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9dd230-b087-cda7-e063-6394a90ae084 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9b0642-53ed-ec94-e063-6394a90aec3d 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d977158-8b5d-66ac-e063-6294a90a4d5c 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Kit SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0eae4b71-60be-9715-e063-6294a90af463 2025-10-20 Warnings Exact identifier application number: M020 Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE Attitude DBA 9055-7588 Qubec Inc. 9ed70230-980c-474c-9f72-a6be0f355124 2025-10-20 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 419b8043-7921-ca77-e063-6394a90a99ba 2025-10-20 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 419c8718-6b9e-3df7-e063-6294a90a1e3b 2025-10-20 Warnings Exact identifier application number: M020 Sonni SunDay Serum ZINC OXIDE Sonni 419d4ada-fe9b-b774-e063-6394a90a3d09 2025-10-20 Warnings Exact identifier application number: M020 Lip Clear Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. 66f84e56-4a5d-4b71-8bd3-79961e7bf4fe 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Strawberry Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 2cafc97f-4cd3-4755-b394-3802c28d4ed5 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Tangerine Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 8a00194e-9e28-4257-82e5-59bc44f7897d 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. c9318a8c-ba3b-4068-84df-110c9005ee1d 2025-10-20 Warnings Exact identifier application number: M020 Terez Honor Hydro Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE DEWYCREAM INC 418d054b-436f-6aa3-e063-6294a90a0f56 2025-10-19 Warnings Exact identifier application number: M020 Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Cosmocos Co., Ltd 41129799-85ed-2de2-e063-6394a90ab40c 2025-10-17 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC c5a67314-e5b2-4dd6-94e9-39c2f286c346 2025-10-17 Warnings Exact identifier application number: M020 LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN ZINC OXIDE Lion Pose Inc. 0310407b-fb74-aa8b-e063-6294a90ad841 2025-10-17 Warnings Exact identifier application number: M020 Thrive Daily Defense Sunscreen Balm SPF30 ZINC OXIDE Thrive Natural Care, Inc 1266bd05-1971-a7f0-e063-6394a90a089c 2025-10-17 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