FDA.reportPublic FDA data

Oars and Alps SPF 35 Face and Scalp Mist

Product NDC
83046-368
11-digit product format
830460368
Labeler code
83046
Product ID
83046-368_ed10b246-aa9b-2b60-e053-2995a90a51d3
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Oars and Alps LLC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-09
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 263 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
application number: M020
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
application number: M020
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d83c576-5dfb-583a-e063-6294a90a2a282024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d833e3b-5330-3c5b-e063-6394a90a2ed22024-12-09WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d9533ba-5606-4116-e063-6294a90ad3b12024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d82121d-1dc2-cd99-e063-6394a90aa7662024-12-09WarningsExact identifier
application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude310e66a2-8714-4016-87f4-81c1fef19ec92024-12-09WarningsExact identifier
application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitudeb6b8733d-6431-4ed2-9350-c63bb901c8042024-12-09WarningsExact identifier
application number: M020
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude06245c8c-93e8-4ebb-bab0-3db64dc178b92024-12-09WarningsExact identifier
application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc7b0d17-d7c8-433f-e053-2995a90a477d2024-12-09WarningsExact identifier
application number: M020
Sheer Zinc SPF 30ZINC OXIDEAllure Labsb6b45dac-41d0-1b55-e053-2a95a90acf612024-12-09WarningsExact identifier
application number: M020
Broad Spectrum SPF30 Mineral SunscreenZINC OXIDEAllure Labsdafc8e62-7c99-1f6d-e053-2995a90a77912024-12-09WarningsExact identifier
application number: M020
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83046-368-648304603686450 mL in 1 BOTTLE, SPRAY (83046-368-64) 50 ml2022-11-090000-00-00NoNoCurrent