Home NDC 49404-157 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30
Product NDC 49404-157
11-digit product format 494040157
Labeler code 49404
Product ID 49404-157_51291c13-9634-7263-e063-6294a90a4d39
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Have & Be Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-09
Substance OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE
Active strength 68; 50; 45; 48 mg/mL; mg/mL; mg/mL; mg/mL
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 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 68 mg/mL ZINC OXIDE 50 mg/mL OCTISALATE 45 mg/mL TITANIUM DIOXIDE 48 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 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 49404-157-01 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 1 in 1 CARTON LOTION 1 2 49404-157-01 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 40 mL in 1 TUBE LOTION 40 2 49404-157-99 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 1 mL in 1 PACKET LOTION 1 2
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 220 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 2499e14a-c14f-ea13-e063-6394a90a62f5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a7bee2-3802-4786-e063-6294a90a6ab5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24aa19c8-86d9-c691-e063-6394a90a691e 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a98d3d-f830-9614-e063-6394a90aa7d1 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM CHAMPAGNE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfb871b-460f-271a-e053-6394a90acad2 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g ZINC OXIDE NAKED SUNDAYS PTY LTD 2f42d22a-983e-d304-e063-6294a90a3719 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM ROSE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfbd0dd-8961-5fd0-e053-6294a90a5de4 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19g AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8% NAKED SUNDAYS PTY LTD 2f47a6c9-dd0a-da94-e063-6294a90a9a45 2025-03-22 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Firming Protocol TITANIUM DIOXIDE AND ZINC OXIDE Obagi Cosmeceuticals LLC 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Brightening Protocol HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 2f75ebf7-d6b6-45c6-ad5b-61739d260ff7 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d37581-122c-ec92-e063-6294a90ab425 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d3ed8c-f424-8d95-e063-6394a90a0cbc 2025-03-21 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. c7142781-fa57-43e5-9436-cb29dd03a669 2025-03-21 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 00ec7d9c-8550-45ce-8d0a-ef2caf84f98d 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Clarifiying Protocol SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 08ba9ea8-73fd-472b-9cc4-67df167352ec 2025-03-21 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3e51da46-6a81-4b74-b16e-3fc298a4ba59 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 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 49404-157-01 49404015701 1 TUBE in 1 CARTON (49404-157-01) / 40 mL in 1 TUBE 1 tube 2026-02-09 No No Current 49404-157-99 49404015799 1 mL in 1 PACKET (49404-157-99) 1 ml 2026-02-09 Yes No Current