Home NDC 65112-304 Sunplus SPF50 Face Body Sunscreen
Product NDC 65112-304
11-digit product format 651120304
Labeler code 65112
Product ID 65112-304_4a08871f-25e4-215d-e063-6394a90ab8a8
Type HUMAN OTC DRUG
Nonproprietary name Sunscreen
Dosage form LOTION
Route TOPICAL
Labeler I.Shay Cosmetics
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-06-01
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength .06; .05; .02; .15 g/118mL; g/118mL; g/118mL; g/118mL
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 Sunplus SPF50 Face Body Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE .06 g/118mL OCTISALATE .05 g/118mL AVOBENZONE .02 g/118mL HOMOSALATE .15 g/118mL
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65112-304-01 Sunplus SPF50 Face Body Sunscreen 118 mL in 1 TUBE LOTION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65112-304 SUNPLUS SPF50 FACE BODY SUNSCREEN (SUNSCREEN) LOTION [I.SHAY COSMETICS] 1 Current NDC, 1 package rows 20241115_26d55baf-66dc-b1b8-e063-6394a90a670d.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 181 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join pavise Lip Defense tinted hydrating oil (hue 604) ZINC OXIDE B.A.I. Biosciences INC. f4ebbc1d-d521-1a47-e053-2a95a90a6f84 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 774) ZINC OXIDE B.A.I. Biosciences INC. f4ebd850-11a8-0d43-e053-2a95a90a2d34 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 616) ZINC OXIDE B.A.I. Biosciences INC. f4eb6b20-7c26-2942-e053-2a95a90abd31 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4346f7a-3642-05d8-e053-2a95a90a013d 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4206dad-6a17-2f56-e053-2a95a90a69dc 2025-10-09 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f434089c-126f-441c-e053-2995a90ab0c7 2025-10-09 Warnings Exact identifier application number: M020 BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) ZINC OXIDE Napoleon PerdisCosmetic Pty Ltd be64bb40-b1a9-2308-e053-2a95a90a69c8 2025-10-09 Warnings Exact identifier application number: M020 Organys Open Formula Sheer ZINC OXIDE Organys Beauty 0b3ab551-cb66-cf86-e063-6394a90a7ab4 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Spa de Soleil 40c03d65-8d09-371a-e063-6294a90a7ac6 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made Sheer ZINC OXIDE Organys Beauty 0b39f550-bd34-509d-e063-6294a90a51d0 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 0b37a73b-73ca-501f-e063-6294a90a6291 2025-10-09 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09b8b8c0-4066-9cbe-e063-6394a90aca24 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift Mineral SPF 30 TITANIUM DIOXIDE Spa de Soleil 40c0e0d2-2c1d-e629-e063-6394a90a5aaf 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 3) ZINC OXIDE Resette, Inc dc89ab76-da32-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 4) ZINC OXIDE Resette, Inc dc89ab0b-d53e-983f-e053-2a95a90a127f 2025-10-09 Warnings Exact identifier application number: M020 Petroleum-Free Lip Balm OCTINOXATE AND OXYBENZONE Medline Industries, LP 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 1) ZINC OXIDE Resette, Inc dc89429a-022c-dd10-e053-2a95a90ac26a 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 2) ZINC OXIDE Resette, Inc dc89ab76-da2f-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Clear Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Spa de Soleil 40c11b19-fc91-2033-e063-6394a90a5a5f 2025-10-09 Warnings Exact identifier application number: M020 Black Girl Sunscreen Make It Mineral Baby ZINC OXIDE Black Girl Sunscreen 302bccc6-7bf3-cc69-e063-6294a90a625c 2025-10-09 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 65112-304-01 65112030401 118 mL in 1 TUBE (65112-304-01) 118 ml 2004-06-01 No No Current