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 133 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
application number: M020
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
application number: M020
Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC374fae34-41b9-4cab-e063-6394a90a9b1d2025-12-11Exact identifier
application number: M020
Z BlocZINC OXIDEThe Maui Medical Group, Inc34b64eb5-a91f-de43-e063-6294a90a80432025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
application number: M020
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC375008f2-8dd4-aa31-e063-6394a90a5be82025-12-11Exact identifier
application number: M020
Replenishing Daily ProtectionZINC OXIDEThe Maui Medical Group, Inc34b96d82-7fcf-e452-e063-6394a90a781b2025-12-11Exact identifier
application number: M020
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
application number: M020
Non Tinted Ultra Zinc Face and BodyZINC OXIDELIV BODY AND BEAUTY LLC3750ffbf-a82d-b4b9-e063-6294a90a7d682025-12-11Exact identifier
application number: M020
The BlockZINC OXIDEELITE ESTHETICS BY NICOLE CAROLINE LLC34a6b17e-6e9e-3f2c-e063-6294a90a1c322025-12-11Exact identifier
application number: M020
SPF 40 Broad Spectrum Non-TintedZINC OXIDETeton Dermatology Holdings, Inc.35093797-008b-b265-e063-6294a90a99492025-12-11Exact identifier
application number: M020
Tinted Zinc ProtectionZINC OXIDETeton Dermatology Holdings, Inc.3508d5a8-9d3c-51d1-e063-6394a90abc8e2025-12-11Exact identifier
application number: M020
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
application number: M020
Antioxidant SPFZINC OXIDETeton Dermatology Holdings, Inc.3509a916-f3e1-9c53-e063-6394a90a5bff2025-12-11Exact identifier
application number: M020
Ultimate Physical Sunscreen TintedZINC OXIDEHALEM DERMATOLOGY PLLC35bb4953-ca8c-e927-e063-6394a90a1a312025-12-11Exact identifier
application number: M020
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact 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