FDA.reportPublic FDA data

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
IngredientStrength
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.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d55baf-66dc-b1b8-e063-6394a90a670dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65112-304-012026-01-29C16284748780-149896155-b02f-586f-e063-e6dba90add90Sunplus SFP50 Face Body Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-304-01Sunplus SPF50 Face Body Sunscreen118 mL in 1 TUBELOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-304SUNPLUS SPF50 FACE BODY SUNSCREEN (SUNSCREEN) LOTION [I.SHAY COSMETICS]1Current NDC, 1 package rows20241115_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 192 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50SUNSCREENSoleil Collective LLC3d4c90e7-0716-4d57-e063-6394a90a43fa2025-08-26WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c4433e2-d383-8326-e063-6294a90aaf982025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50SUNSCREENSoleil Collective LLC3d4d1b94-b1ce-cf94-e063-6394a90a61ba2025-08-26WarningsExact identifier
application number: M020
naked TURTLE 30ZINC OXIDENAKED TURTLE SUNSCREEN LLC65f1570a-6156-40e6-a792-e0707607dc2f2025-08-26WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF 50ZINC OXIDEDelta Ecommerce LLC2d490531-af38-87d0-e063-6394a90acf492025-08-25WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC20d24c9d-9558-156d-e063-6294a90a2d1a2025-08-25WarningsExact identifier
application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC413275e8-0011-471e-9539-ea95ed8384132025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - BananaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d34d144-2515-d7fa-e063-6294a90abb3f2025-08-25WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 sunscreenAVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%Florida Squeezed393b59aa-6d5a-4757-9f6d-59f7533aee862025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d37ec29-8d15-c716-e063-6394a90ae7092025-08-25WarningsExact identifier
application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADOREZINC OXIDERms organics LLC3d386cc9-e097-dacf-e063-6294a90a8fe22025-08-25WarningsExact identifier
application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d3a0d5c-a366-22fc-e063-6394a90a308b2025-08-25WarningsExact identifier
application number: M020
BOB Kids Sun Balm SPF 40ZINC OXIDE 23%SPF Ventures, LLCefa5c501-273c-5e97-e053-2995a90a865b2025-08-24WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCe4a2e6e4-5c35-4178-b341-65644233b7b82025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC57f91218-2477-4495-98e8-c512d823e1582025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc358745d-b9c0-4a9e-9a83-caffa04ea2e52025-08-22WarningsExact identifier
application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC050c2997-3ec0-4515-8a67-709b07a5010f2025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf3e27d-ab16-4f12-e063-6394a90a70e22025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf42e31-4e11-9b6d-e063-6294a90aa7412025-08-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65112-304-0165112030401118 mL in 1 TUBE (65112-304-01) 118 ml2004-06-01NoNoCurrent