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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bright as Day Mineral SPF50ZINC OXIDEKoco Life LLC1c245a53-4098-62e6-e063-6294a90abf122024-09-23WarningsExact identifier
application number: M020
Pure Protect Mineral Sunscreen Stick SPF50ZINC OXIDEKoco Life LLC22cd5999-9b9a-91a3-e063-6394a90a0da52024-09-23WarningsExact identifier
application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.229dabbc-9043-3c9d-e063-6394a90a56922024-09-21WarningsExact identifier
application number: M020
GLC OG Natural Tinted SPF 30 SunscreenZINC OXIDEGUD LIFE CO. LLC25e1e8ec-e19d-45f7-b339-5d12c2b511d62024-09-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENETARGET CORPORATIONbad7d56e-662e-0776-e053-2a95a90a0af02024-09-18WarningsExact identifier
application number: M020
Target Up and Up Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb82b6d0d-616d-f041-e053-2995a90ae6a32024-09-18WarningsExact identifier
application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA LLC43d293f6-e13c-4ee9-89df-2a3ef0034e312024-09-16WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEAllure Labs22042031-ac8e-1ab2-e063-6394a90a6ed42024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEONESKIN INC.2204e776-b1a1-be15-e063-6294a90af5de2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEAllure Labs2205345b-5e92-37eb-e063-6294a90a6b6c2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf4130277-ea9b-6b25-e053-2a95a90a59be2024-09-13WarningsExact identifier
application number: M020
HEB SPF 50 Tattoo Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6df491d-1fa9-a4c8-e053-6394a90a38662024-09-13WarningsExact identifier
application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENESkin Ai, LLC21cbd5ac-5307-939b-e063-6294a90ac7912024-09-10WarningsExact identifier
application number: M020
Mario Badescu SPF 17AVOBENZONE, OCTINOXATE, OCTOCRYLENEBentley Laboratories LLC0fd51f8d-ee67-48fd-ab98-1fedb03394622024-09-10WarningsExact identifier
application number: M020
Mario Badescu Collagen SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC0246b11b-f1ba-4f47-91ab-52a6554b94672024-09-10WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLCf6d653f5-52a0-42ad-8308-b8d6f57050cc2024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBentley Laboratories LLCfe485d4c-0ded-4061-ac34-77b72d5350902024-09-10WarningsExact 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