Home NDC 49358-604 Hydrating Sheer Lip Balm SPF 30 - SHIMMER
Product NDC 49358-604
11-digit product format 493580604
Labeler code 49358
Product ID 49358-604_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 49358-604-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 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 49358-604-01 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 - SHIMMER
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 49358-604-01 Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen 1 in 1 CARTON LIPSTICK 1 2 49358-604-01 Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad 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 49358-604 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 215 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC ce93b371-26ab-4493-98e0-98234c3a9ba6 2025-05-01 Warnings Exact identifier application number: M020 Winter Rescue Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. 24356548-348d-2cd2-e063-6294a90ab352 2025-04-29 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 CLEAR LIP 30 CLEAR The Center Brands, LLC 33d5d1d4-c516-238c-e063-6294a90ac11c 2025-04-28 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BEL STAR SA 33db89ac-2653-78f5-e063-6394a90af03d 2025-04-28 Warnings Exact identifier application number: M020 Lifeguard SUNSCREEN SPHERE 8 INC 32be4eb3-f106-182d-e063-6394a90aa484 2025-04-28 Warnings Exact identifier application number: M020 Practical Alchemy Purify and Protect Duo MICELLAR WATER WIPES AND ZINC OXIDE Over Here, LLC 28514e58-59a6-094a-e063-6394a90a1c7d 2025-04-28 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2fbf7f9d-dba7-48f9-b10e-63225e8f1399 2025-04-25 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380a271-1538-2e3a-e063-6294a90a90a2 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380f1ac-0320-35f2-e063-6394a90a97eb 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE 15% Yunqi Cosmetics (Shenzhen) Co., Ltd 33813fe1-8496-d541-e063-6294a90a6254 2025-04-24 Warnings Exact identifier application number: M020 Sunstation Sport Sunscreen SPF 30 OCTISALATE, OCTOCRYLENE, ZINC OXIDE Impact Melanoma Inc ba78aa73-a25b-4a8e-99b2-9262bb9a7d27 2025-04-24 Warnings Exact identifier application number: M020 Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 42819c8d-cc0a-4bee-95db-39a69ce7f660 2025-04-24 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 338c2c66-497a-f7d1-e063-6294a90a7789 2025-04-24 Warnings Exact identifier application number: M020 The Ordinary UV Filters SPF 45 Serum HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE Deciem 10cde253-26ee-b97d-e063-6394a90a8302 2025-04-23 Warnings Exact identifier application number: M020 BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin C ZINC OXIDE VeganicSKN 3123aab6-0407-19e5-e063-6394a90a5bd8 2025-04-23 Warnings Exact identifier application number: M020 Sephora Daily Sunscreen Cream Broad Spectrum SPF 30 ZINC OXIDE S+ b49e043b-8164-421c-a02b-3dab0be1454d 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Sports Cream ZINC OXIDE YAYA ORGANICS L.L.C. 9eabf1f8-698b-4fa8-98d3-3696c35b044c 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Baby Kids Mineral Sunscreen ZINC OXIDE YAYA ORGANICS L.L.C. 3275303d-a448-4fb4-bdce-6442823f8996 2025-04-22 Warnings Exact identifier application number: M020 Oathology Inzincable Sunscreen SPF 50 HOMOSALATE, OCTOCRYLENE, ZINC OXIDE SKINOATH LLC d245dfca-9e32-4e71-9df8-58fff84ef6a9 2025-04-22 Warnings Exact identifier application number: M020 Back9ine Skincare Pure Invisible Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Back 9ine Skincare, LLC 974ede40-cfb5-4612-b168-5d42dd137f63 2025-04-22 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 49358-604-01 49358060401 1 APPLICATOR in 1 CARTON (49358-604-01) / 4.2 g in 1 APPLICATOR 1 applicator 2023-07-01 No No Current