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 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 49358-600-01 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 126 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Safe Lip Balm TITANIUM DIOXIDE, ZINC OXIDE REVIVE IN SOLANO 36c4f0c9-5789-ca58-e063-6394a90a2323 2025-12-15 Exact identifier application number: M020 Titanium Dioxide, Zinc Oxide ON THE GO SUNSCREEN STICK REVIVE IN SOLANO 36c57e6f-c747-9926-e063-6294a90a5721 2025-12-15 Exact identifier application number: M020 Daily Shade Dewy Glow Tinted ZINC OXIDE BLISS BEAUTY LLC 373babab-2949-5474-e063-6394a90aacd7 2025-12-15 Exact identifier application number: M020 Daily Shade Matte Tinted TITANIUM DIOXIDE, ZINC OXIDE BLISS BEAUTY LLC 3739bdb8-2152-b2ba-e063-6294a90acd94 2025-12-15 Exact identifier application number: M020 Daily Shade Matte Tinted TITANIUM DIOXIDE, ZINC OXIDE BLISS BEAUTY LLC 37396a51-225d-7669-e063-6294a90af6d3 2025-12-15 Exact identifier application number: M020 Daily Shade Dewy Glow Tinted ZINC OXIDE BLISS BEAUTY LLC 373a4c37-e280-bacb-e063-6394a90a5af8 2025-12-15 Exact identifier application number: M020 Daily Shade Sheer Matte ZINC OXIDE BLISS BEAUTY LLC 373a0d67-b225-ecb0-e063-6294a90a9ac1 2025-12-15 Exact identifier application number: M020 Daily Shade Sheer Matte ZINC OXIDE BLISS BEAUTY LLC 373b3e56-f923-dd24-e063-6294a90acf53 2025-12-15 Exact identifier application number: M020 Tinted Lip Shade Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BLISS BEAUTY LLC 373a7c01-ba9f-4b00-e063-6294a90ae1a2 2025-12-15 Exact identifier application number: M020 Daily Shade Matte Tinted TITANIUM DIOXIDE, ZINC OXIDE BLISS BEAUTY LLC 373b7ab9-c692-fc1b-e063-6294a90aa803 2025-12-15 Exact identifier application number: M020 Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted ZINC OXIDE True Beauty Brows & Skin Care 37dc4599-bd97-8c85-e063-6294a90ad1dc 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BASS & KLASS, INC 36af24e2-015a-a9a7-e063-6294a90a2fce 2025-12-15 Exact identifier application number: M020 Tinted Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BASS & KLASS, INC 36add3a3-f1ff-3986-e063-6394a90ab7fe 2025-12-15 Exact identifier application number: M020 Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted ZINC OXIDE True Beauty Brows & Skin Care 37dc70ba-a6bb-fe09-e063-6394a90a5129 2025-12-15 Exact identifier application number: M020 COOLA BARE REPUBLIC CLEARSCREEN SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC bcbab676-fbe2-f0cc-e053-2a95a90ad4d2 2025-12-15 Warnings Exact identifier application number: M020 COOLA BARE REPUBLIC CLEARSCREEN SPF100 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC f14cf2b8-b110-1210-e053-2995a90a0102 2025-12-15 Warnings Exact identifier application number: M020 COOLA BARE REPUBLIC CLEARSCREEN SPF100 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC f1504311-4865-5499-e053-2995a90acdcd 2025-12-15 Warnings Exact identifier application number: M020 COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC f14d70f1-440b-900d-e053-2995a90a30a0 2025-12-15 Warnings Exact identifier application number: M020 REVERSE Brightening Defense Fluid AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Rodan & Fields dc230e1e-bfb8-4d7c-bad5-bff77d78220e 2025-12-15 Warnings Exact identifier application number: M020 COOLA BARE REPUBLIC MINERAL SPORT SPF50 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC bbf15e58-c160-d599-e053-2a95a90a0696 2025-12-14 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 49358-600-01 49358060001 1 APPLICATOR in 1 CARTON (49358-600-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current