Home NDC 49358-600 Hydrating Sheer Lip Balm SPF 30 -Crystal
Product NDC 49358-600
11-digit product format 493580600
Labeler code 49358
Product ID 49358-600_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 49358-600-01 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 49358-600-01 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 49358-600-01 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 49358-600-01 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 49358-600-01 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 49358-600-01 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 49358-600-01 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 -Crystal
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 49358-600-01 Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen 4.2 g in 1 APPLICATOR LIPSTICK 4.2 2 49358-600-01 Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen 1 in 1 CARTON LIPSTICK 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49358-600 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 110 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TINTED TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad4442-e45f-90e2-e063-6294a90aeef5 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d8b849-cf73-e008-e063-6394a90a410a 2025-12-17 Exact identifier application number: M020 TINTED RESTORATIVE MOISTURIZER ZINC OXIDE SKINERGIX LLC 3636adf0-c3bd-7422-e063-6394a90aaccc 2025-12-17 Exact identifier application number: M020 Premier Zinc ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3bb378c8-14b0-aa13-e063-6294a90a4db3 2025-12-17 Warnings Exact identifier application number: M020 Protect and Renew ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3bb479ed-1153-8e80-e063-6294a90a2937 2025-12-17 Warnings Exact identifier application number: M020 Flawless Finish TITANIUM DIOXIDE, ZINC OXIDE ENSO SKINCARE & WELLNESS LLC 3b8df7ce-e5ce-aaf8-e063-6394a90afdae 2025-12-17 Warnings Exact identifier application number: M020 Shield Mineral Sunscreen Tinted ZINC OXIDE SMOOTHE LLC 369b9d76-f6c3-e25f-e063-6294a90adaf3 2025-12-17 Exact identifier application number: M020 Shield Mineral Sunscreen Non Tinted ZINC OXIDE SMOOTHE LLC 369bc20d-7192-7c0a-e063-6294a90a3dfe 2025-12-17 Exact identifier application number: M020 Lip Balm TITANIUM DIOXIDE, ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369d63a9-b9a9-9530-e063-6394a90ac8ef 2025-12-17 Exact identifier application number: M020 Matte Tint TITANIUM DIOXIDE, ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369ced69-59b4-0f3c-e063-6294a90a582f 2025-12-17 Exact identifier application number: M020 Hydra Tint ZINC OXIDE PATRICIA SOLIS MAKEUP ARTIST, LLC 369d4e7a-8356-8f15-e063-6394a90acca8 2025-12-17 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 49358-600-01 49358060001 1 APPLICATOR in 1 CARTON (49358-600-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current