FDA.reportPublic FDA data

ARAMORE MULTI-DEFENSE SUNSCREEN - AM

Product NDC
83127-101
11-digit product format
831270101
Labeler code
83127
Product ID
83127-101_4849ec6e-9a24-c7aa-e063-6394a90a070d
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
New Frontier Bio, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-09
Substance
ZINC OXIDE
Active strength
20 g/100mL
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
ARAMORE MULTI-DEFENSE SUNSCREEN - AM
Brand name suffix
Broad Spectrum SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ef6c8443-fd10-2022-e053-2a95a90a45eaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83127-101-11ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 3050 mL in 1 TUBELOTION504
83127-101-12ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 301 in 1 BOXLOTION14
83127-101-13ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 3015 mL in 1 TUBELOTION154
83127-101-14ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 301 in 1 BOXLOTION14
83127-101-15ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 305 mL in 1 TUBELOTION54
83127-101-16ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 301 in 1 BOXLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83127-101ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [NEW FRONTIER BIO, INC]3Current NDC, Legacy NDC, 6 package rows20240202_ef6c8443-fd10-2022-e053-2a95a90a45ea.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 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
application number: M020
Intelligent Defense Mineral SunscreenZINC OXIDEGLO PHARMA4ab664aa-5f0c-7ddb-e063-6294a90a97532026-02-12WarningsExact identifier
application number: M020
Sky and Sol Sports SunscreenZINC OXIDEDelta Ecommerce LLC4dd054cd-8f53-4210-e063-6394a90ade272026-02-12WarningsExact identifier
application number: M020
Sky and Sol Kids and Babies SunscreenZINC OXIDEDelta Ecommerce LLC4de67653-ab31-c6b2-e063-6394a90a7e8c2026-02-12WarningsExact identifier
application number: M020
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83127-101-118312701011150 mL in 1 TUBE (83127-101-11) 50 ml2022-12-090000-00-00NoNoCurrent
83127-101-12831270101121 TUBE in 1 BOX (83127-101-12) / 50 mL in 1 TUBE (83127-101-11) 1 tube2022-12-09NoNoCurrent
83127-101-138312701011315 mL in 1 TUBE15 mlHistorical
83127-101-14831270101141 TUBE in 1 BOX (83127-101-14) / 15 mL in 1 TUBE (83127-101-13) 1 tube2022-12-09NoNoCurrent
83127-101-15831270101155 mL in 1 TUBE5 mlHistorical
83127-101-16831270101161 TUBE in 1 BOX (83127-101-16) / 5 mL in 1 TUBE (83127-101-15) 1 tube2022-12-09NoNoCurrent