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 185 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELROEL Pang Pang Sun Cushion Plus ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE MONOGLOT HOLDINGS Inc. 5ffaad65-f0b2-416a-b0a3-b92e880641e4 2025-09-18 Warnings Exact identifier application number: M020 e.l.f. Camo CC Cream SPF 30 Fair 125 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 407f9c0d-31c6-f5bb-e063-6394a90a4db4 2025-09-18 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1630feee-7e0d-c6f4-e063-6294a90a7b1c 2025-09-17 Warnings Exact identifier application number: M020 Guise Tinted Drops ZINC OXIDE Donis Men LLC 3f039049-5004-2888-e063-6294a90a5150 2025-09-17 Warnings Exact identifier application number: M020 ONE SIZE ON TIL DAWN ONE SIZE ON TIL DAWN Pogi Beauty LLC 3f05d90b-9274-4d21-e063-6294a90a8485 2025-09-17 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DP3 ZINC OXIDE PUR Minerals 3f073413-b314-e5da-e063-6394a90a9ab4 2025-09-17 Warnings Exact identifier application number: M020 e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 3fa7ef54-2c4d-9883-e063-6294a90a8d88 2025-09-17 Warnings Exact identifier application number: M020 CVS SPF 50 Face Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CVS 26a69a47-947a-a478-e063-6394a90aa468 2025-09-16 Warnings Exact identifier application number: M020 SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE Skin Authority LLC 5eb27be9-9e80-4f4a-b193-b918d831555d 2025-09-15 Warnings Exact identifier application number: M020 Sun and Honey Tallow Sunscreen SPF 30 ZINC OXIDE Amara Ventures 3eda8a70-7c9e-e920-e063-6394a90a85a2 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3edcc26a-d960-3fa8-e063-6394a90ab703 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3ede5e54-4c9f-02f7-e063-6294a90a9df6 2025-09-15 Warnings Exact identifier application number: M020 I.C. Industrial Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc b89d687a-7b36-4643-9817-765d4710ca60 2025-09-15 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 97795f0e-d867-4e17-b7c9-ede08e7df70c 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2d05659c-57d2-4faf-ab67-1b8d68945aed 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 5ff2b9e4-a778-4667-8c3c-3561317b374a 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. bc4f909f-3e2c-4fd7-a129-3c2fac8259f0 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2dd9a30a-2cde-44c0-9350-3aeab9f7091b 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint ZINC OXIDE Dolce & Gabbana Beauty S.R.L e375412e-8685-49a2-b1b0-00ab114e14b7 2025-09-12 Warnings Exact identifier application number: M020 Beach Club Mineral Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc d9aae241-229e-4123-abe9-99f74f5ab0b3 2025-09-12 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 49358-601-01 49358060101 1 APPLICATOR in 1 CARTON (49358-601-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current