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 268 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands, LLC92fdea59-c19d-627a-e053-2995a90aabdc2024-11-25WarningsExact identifier
application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsExact identifier
application number: M020
MILKY MINERAL SUN SERUMTITANIUM DIOXIDE AND ZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity53834c89-b3b4-4e21-b9f6-19f95e78ba832024-11-21WarningsExact identifier
application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
application number: M020
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
application number: M020
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
application number: M020
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20ENSULIZOLENOXELL CORPORATION8528aa01-fd4b-58a6-e053-2991aa0a3d6a2024-11-20WarningsExact identifier
application number: M020
Facial Skin Shield Broad Spectrum SPF50 PlusAVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdbb62c700-be07-4fe3-b007-425a5f760b302024-11-20WarningsExact identifier
application number: M020
FOUNDATION LIGHT SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273ea785-241b-3e10-e063-6294a90a9fff2024-11-19WarningsExact identifier
application number: M020
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50ZINC OXIDEPOOLBARc081acef-9e1d-4aa6-b49c-c92fe28af2c72024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR1721023c-3321-4f0b-a053-6d0c657fa1b02024-11-19WarningsExact identifier
application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
application number: M020
Fresh Monster Mineral SunscreenZINC OXIDEBlue Zebra Brands, Inc.230cc36d-5163-f423-e063-6394a90a81242024-11-19WarningsExact identifier
application number: M020
Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades)OCTINOXATE AND TITANIUM DIOXIDENoxell356af30e-82c7-4e28-94bb-b536e74d01e12024-11-19WarningsExact identifier
application number: M020
Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades)TITANIUM DIOXIDENoxell Corporationfab59bd6-4ef6-4626-9f75-edcd4088e6432024-11-19WarningsExact 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