Home NDC 65278-319 Advanced Sun Resistance SPF 30
Product NDC 65278-319
11-digit product format 652780319
Labeler code 65278
Product ID 65278-319_18f879f0-3d5c-0067-e063-6394a90a9db3
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone
Dosage form CREAM
Route TOPICAL
Labeler June Jacobs Labs, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-20
Substance AVOBENZONE; OXYBENZONE; OCTINOXATE; HOMOSALATE; OCTISALATE
Active strength 3.371; 6.743; 8.429; 11.238; 5.619 g/112.38g; g/112.38g; g/112.38g; g/112.38g; g/112.38g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Advanced Sun Resistance SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3.371 g/112.38g OXYBENZONE 6.743 g/112.38g OCTINOXATE 8.429 g/112.38g HOMOSALATE 11.238 g/112.38g OCTISALATE 5.619 g/112.38g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65278-319-01 Advanced Sun Resistance SPF 30 112.38 g in 1 TUBE CREAM 112.38 1 65278-319-02 Advanced Sun Resistance SPF 30 112.38 g in 1 CARTON CREAM 112.38 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65278-319 ADVANCED SUN RESISTANCE SPF 30 (HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC] 1 Current NDC, 2 package rows 20240529_18f879f0-3d5b-0067-e063-6394a90a9db3.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 46 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e276e4-81f1-9429-e063-6394a90a800d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 106a9608-f7a4-0f8c-e063-6394a90a26ab 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fced72-39f9-f3a3-e063-6294a90a8b73 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc2a82-260c-7cd3-e063-6394a90af2c1 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd9aa5-dbd6-e5a7-e063-6394a90a3eac 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc93a7-f5be-965d-e063-6394a90ab335 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd1661-1b91-b65b-e063-6394a90af89b 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Lipkist Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fbcb81-2735-53c8-e063-6394a90ab0fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd8776-99f8-e5a4-e063-6394a90a2033 2026-04-09 Warnings Exact identifier application number: M020 uLOOK Sunscreen SPF 50 SUNSCREEN HAMEX GLOBAL COSMETICS LLC 4e05588c-486b-60e0-e063-6294a90af457 2026-04-09 Warnings Exact identifier application number: M020 Pro-Tect Sports Sunscreen SPF 20 MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE ABBE Laboratories, Inc. 35869e8d-8e48-4b22-8af3-6964fe8ac182 2026-04-09 Warnings Exact identifier application number: M020 Sunright 50 AVOBENZONE, HOMOSALATE, AND OCTINOXATE NSE Products, Inc. b1b76481-da23-427f-9b34-b987019fa532 2026-04-09 Warnings Exact identifier application number: M020 ThinkBaby SPF 30 ZINC OXIDE thinkOperations,LLC 06862b00-c937-41af-ab5d-cea34160d035 2026-04-09 Warnings Exact identifier application number: M020 Nutricentials Day Dream Protective HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE NSE Products, Inc. 4a376e93-85e8-40a5-8641-d3e3d11fdeea 2026-04-08 Warnings Exact identifier application number: M020 AGE20S SUNSCREEN DUO ZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Aekyung Industrial Co., Ltd. 4eef11cd-85a1-0e44-e063-6394a90a5d44 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE DEEP SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef430e8-cdc8-2897-e063-6394a90a3ac7 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE LIGHT SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef4a822-a7ab-b374-e063-6394a90a8508 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef4d44e-3421-535f-e063-6294a90a2fea 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Acupac Packaging, Inc. 4ef5baf7-00b1-97aa-e063-6294a90aab9c 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Face SPF 70 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef5dcd4-b2d0-bcd1-e063-6294a90a871f 2026-04-08 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 65278-319-01 65278031901 112.38 g in 1 TUBE (65278-319-01) 112.38 g 2021-03-20 No No Current 65278-319-02 65278031902 112.38 g in 1 CARTON (65278-319-02) 112.38 g 2021-03-20 No No Current