FDA.reportPublic FDA data

SUN CONTROL BROAD SPECTRUM SPF 30

Product NDC
84259-475
11-digit product format
842590475
Labeler code
84259
Product ID
84259-475_161fc0cf-491c-2123-e063-6294a90aaa7a
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SKINPLAN.US LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-22
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
70; 50; 60 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
SUN CONTROL BROAD SPECTRUM SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE70 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e34a343-7253-469f-9973-076a7ae26cbcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84259-475-00SUN CONTROL BROAD SPECTRUM SPF 30100 mL in 1 TUBECREAM1001
84259-475-00SUN CONTROL BROAD SPECTRUM SPF 301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84259-475SUN CONTROL BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SKINPLAN.US LLC]1Current NDC, 2 package rows20240423_8e34a343-7253-469f-9973-076a7ae26cbc.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 79 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC42c8fd50-73c6-480b-9d7e-31157e5869292026-01-16WarningsExact identifier
application number: M020
HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30ZINC OXIDEKENDO HOLDINGS INC.18fb7472-746f-339a-e063-6294a90a267d2026-01-16WarningsExact identifier
application number: M020
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50ZINC OXIDENoble Panacea Labs, Inc.aed57f81-4b7d-42dc-993e-6bb10f93b02a2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
application number: M020
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
application number: M020
BeautyBarrierZINC OXIDENAKED SUNDAYS PTY LTD45740afa-230d-4dd5-e063-6394a90a102f2026-01-15WarningsExact identifier
application number: M020
Glow This WayOCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATEKoco Life LLC4619cf96-987a-3e88-e063-6294a90afbe92026-01-15WarningsExact identifier
application number: M020
Reef safe lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.486930f2-026b-14b4-e063-6394a90aa0312026-01-15WarningsExact identifier
application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC316bf6f8-7d30-2560-e063-6294a90afb8a2026-01-15WarningsExact identifier
application number: M020
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
application number: M020
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEVolition Beauty2631de4b-66e3-0547-e063-6394a90a822c2026-01-15WarningsExact identifier
application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30ZINC OXIDESKINN COSMETICS, LLC350ed168-ab3b-f314-e063-6394a90a8bbf2026-01-15WarningsExact identifier
application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEStriVectin Operating Company, Inc.4873a262-a19b-555e-e063-6394a90a182a2026-01-15WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLCe843bb6b-257f-4425-95bc-41774e032a092026-01-15WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLC1e18f1dd-a4e4-455a-9699-5634b95596782026-01-15WarningsExact identifier
application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84259-475-00842590475001 TUBE in 1 BOX (84259-475-00) / 100 mL in 1 TUBE1 tube2024-04-22NoNoCurrent