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 335 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF 30 Sun StickBROAD SPECTRUM SPF 30 SUN STICKRaining Rose, Inca35a7973-443b-5247-e053-2a95a90a44592023-10-23WarningsExact identifier
application number: M020
Cranberry Orange SPF 15 Broad Spectrum Lip BalmCRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c3aa41-c9a0-4f64-e053-2995a90a005e2023-10-23WarningsExact identifier
application number: M020
Super Mint SPF 15 Broad Spectrum Lip BalmSUPER MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9626a2f-9931-78d2-e053-2995a90ac40f2023-10-23WarningsExact identifier
application number: M020
Spearmint SPF 30 Broad Spectrum Lip BalmSPEARMINT SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b520dc-bae6-614f-e053-2995a90ae6772023-10-23WarningsExact identifier
application number: M020
Citrus SPF 15 Broad Spectrum Lip BalmCITRUS SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d0651-6001-29ce-e053-2a95a90a967f2023-10-23WarningsExact identifier
application number: M020
Coconut Mineral SPF 15 Broad Spectrum Lip BalmCOCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0d2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Vanilla SPF 30 Broad Spectrum Lip BalmVANILLA SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Incb7b542fa-b0c2-7b33-e053-2995a90a71192023-10-23WarningsExact identifier
application number: M020
Pineapple Mineral SPF 15 Broad Spectrum Lip BalmPINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incb7c6684f-1122-20c1-e053-2995a90ae6cf2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
application number: M020
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
application number: M020
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
application number: M020
Caribbean Breeze SPF 15 Broad Spectrum Lip BalmCARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a42f6-27d1-e2cc-e053-2a95a90aa6da2023-10-23WarningsExact identifier
application number: M020
Iced Pear SPF 15 Broad Spectrum Lip BalmICED PEAR SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8c4a0ec-e07e-1cda-e053-2a95a90a0f3f2023-10-23WarningsExact identifier
application number: M020
Lemonade SPF 15 Broad Spectrum Lip BalmLEMONADE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca8ffc32b-b758-0f8f-e053-2995a90adb622023-10-23WarningsExact identifier
application number: M020
Strawberry SPF 15 Broad Spectrum Lip BalmSTRAWBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902d590-0726-ad6f-e053-2995a90a11302023-10-23WarningsExact identifier
application number: M020
Orange Creamsicle SPF 15 Broad Spectrum Lip BalmORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9005cb1-ae1a-7736-e053-2995a90a28ea2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLCf2f3601f-081a-4bae-e053-2a95a90a4fac2023-10-23WarningsExact identifier
application number: M020
Neora Age IQ Invisi-Bloc SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeora, LLC82f48635-1dc4-8c0d-e053-2991aa0a60cc2023-10-23WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1TITANIUM DIOXIDEAmway Corp7494fe09-40e0-4152-9974-a6e8a4d7f4212023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1TITANIUM DIOXIDEAmway Corpcec51b88-a6b8-4b64-b3aa-830e712a3c8a2023-10-22WarningsExact 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