FDA.reportPublic FDA data

Equate

Product NDC
49035-759
11-digit product format
490350759
Labeler code
49035
Product ID
49035-759_249e9a6e-b52d-0c56-e063-6394a90a6664
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-04
Substance
HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
150; 30; 50; 70 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
Equate
Brand name suffix
SPF 50 Ultra Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE150 mg/mL
AVOBENZONE30 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f02f297-5315-ced4-e053-2a95a90a8c7bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-759-12EquateSPF 50 Ultra Sunscreen236 mL in 1 TUBELOTION2365
49035-759-14EquateSPF 50 Ultra Sunscreen473 mL in 1 BOTTLE, PLASTICLOTION4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-759EQUATE SPF 50 ULTRA SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20241018_8f02f297-5315-ced4-e053-2a95a90a8c7b.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 318 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d584-7cb6-a078-e053-2995a90ac78f2023-12-05WarningsExact identifier
application number: M020
EltaMD UV SheerZINC OXIDE AND OCTOCRYLENE SUNSCREENCP Skin Health Group, Inc.2564e811-70f5-4d00-be8e-686b55e316302023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1720cff-a897-68cb-e053-2995a90a30b62023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4ed-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4f0-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228ca6-8fb4-5964-e053-2a95a90a30ca2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12292a8-c98f-eb27-e053-2a95a90a9bbc2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d22a-0315-8e84-e053-2995a90a30b52023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172cabe-faab-6458-e053-2995a90aef662023-12-05WarningsExact identifier
application number: M020
Sea Clearly Translucent Gel Sunscreen BS SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAllure Labs0bb4ec66-64ba-9583-e063-6394a90ac5122023-12-04WarningsExact identifier
application number: M020
Clearly Zinq Mineral Gel Sunscreen BS SPF 60ZINC OXIDEAllure Labs0bb7f0a4-13df-7734-e063-6294a90a242b2023-12-04WarningsExact identifier
application number: M020
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skinTITANIUM DIOXIDE, ZINC OXIDERodan & Fieldsb7401ff8-ca47-4c74-813c-99c5f28c0b6d2023-12-04WarningsExact identifier
application number: M020
Eminence Bright Skin Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Care4f2ba93d-ec19-40c1-b4ca-53898841f55b2023-12-02WarningsExact identifier
application number: M020
Lilikoi Mineral Defense Sport Sunscreen SPF 30ZINC OXIDEEminence Organic Skin Care Ltd.5375522a-17e3-48a1-8248-dd811c3823bf2023-12-02WarningsExact identifier
application number: M020
Eminence Lilikoi Daily Defense Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Careedc9972a-affd-4099-aec1-3549a07fa83c2023-12-02WarningsExact identifier
application number: M020
Perbelle CC SPF43 UVA UVB Broad SpectrumTITANIUM DIOXIDEPerbelle Cosmetics Global Ltd.b5e2724e-9806-5bcc-e053-2a95a90a05082023-12-01WarningsExact identifier
application number: M020
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.abd8b302-a01c-478d-919a-22e686cb88da2023-12-01WarningsExact identifier
application number: M020
SHADE and ILLUMINATE SOFT RAD PRMR SPFOCTINOXATE,OCTISALATE,ZINC OXIDETOM FORD BEAUTY DISTeac7d416-c243-4647-e053-2a95a90abcb72023-12-01WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228d15-a157-6989-e053-2995a90a44ea2023-12-01WarningsExact identifier
application number: M020
CAO Cosmetic Lip Sunscreen SPF 30AVOBENZONE, OCTOCRYLENES & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITEDd912b9e9-f351-e2b0-e053-2a95a90a9ca22023-11-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-759-1249035075912236 mL in 1 TUBE (49035-759-12) 236 ml2019-06-040000-00-00NoNoCurrent
49035-759-1449035075914473 mL in 1 BOTTLE, PLASTIC (49035-759-14) 473 ml2019-06-040000-00-00NoNoCurrent