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 284 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape ScentedZINC OXIDEH.E.B.f58ed2f9-67c3-ce91-e053-2995a90a12292024-10-15WarningsExact identifier
application number: M020
HEB Shimmer Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5930029-4c96-2576-e053-2995a90a7bed2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5a3313e-4935-1ce3-e053-2a95a90a6ad12024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b6caf2-ebff-79fb-e053-2995a90ac2f82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf59461e3-9521-6a7b-e053-2a95a90a73b82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2c266-6fc9-21ae-e053-2995a90aec0e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b7172a-b8fc-0d11-e053-2a95a90a9f732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Peach Bellini Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cbac04-361f-9226-e053-2995a90a2d7b2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Cucumber Water Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5d933cf-3461-8b03-e053-2a95a90ad79f2024-10-15WarningsExact identifier
application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.Bf6ce4ea0-d92f-368c-e053-6294a90a2a812024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2702c-5451-58a1-e053-2a95a90adb8e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cb5f9a-6691-37c3-e053-2a95a90a9af02024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Rosewater Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5db7ec6-0e9b-7044-e053-2a95a90a1e482024-10-15WarningsExact 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