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 334 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1OCTINOXATE, OXYBENZONEAmway Corpd810bbe7-a889-4737-9a78-d996fec711222023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1OCTINOXATE, OXYBENZONEAmway Corp0039ca4d-2a0c-4b19-a029-1c080fc292ce2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1OCTINOXATE, OXYBENZONEAmway Corp410592f1-57f5-4c17-8162-a0c088f0bf272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1OCTINOXATE, OXYBENZONEAmway Corpe4e61943-ec96-467c-8921-ee531ef4f13d2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1OCTINOXATE, OXYBENZONEAmway Corp62ff0eea-b67e-476c-b7f2-0fcaed9dc2272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1OCTINOXATE, OXYBENZONEAmway Corp179e5268-8eca-40b7-aa7f-ede221fa9c892023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1OCTINOXATE, OXYBENZONEAmway Corp8a3fcfaa-5bfa-4f77-932f-bfb75628c9c62023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1OCTINOXATE, OXYBENZONEAmway Corp18c11289-9cc0-4a37-a299-ee3c358dbeca2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1OCTINOXATE, OXYBENZONEAmway Corpd7cb8e53-a36f-43d1-9918-f5680aafb2c42023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2OCTINOXATE, OXYBENZONEAmway Corp01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f52023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1OCTINOXATE, OXYBENZONEAmway Corpff9c6565-a942-494f-af8c-557974675db82023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1OCTINOXATE, OXYBENZONEAmway Corp9ca531ae-10b5-4791-b62c-37b99bc1d4ea2023-10-23WarningsExact identifier
application number: M020
g and h Protect BodyENSULIZOLE, OCTISALATE, ZINC OXIDEAccess Business Group LLC03768ff4-0c67-48b3-a2f3-321d0a6790e82023-10-23WarningsExact identifier
application number: M020
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
application number: M020
Coconut SPF 15 Broad Spectrum Lip BalmCOCONUT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d28eb-2f41-7146-e053-2a95a90a86722023-10-23WarningsExact identifier
application number: M020
Bubblegum SPF 15 Broad Spectrum Lip BalmBUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7590383-661f-5b1e-e053-2995a90a197e2023-10-23WarningsExact identifier
application number: M020
Blackberry Smoothie SPF 15 Broad Spectrum Lip BalmBLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7577d5f-69d8-3f32-e053-2995a90aaba52023-10-23WarningsExact identifier
application number: M020
Breath Fresh SPF 15 Broad Spectrum Lip BalmBREATH FRESH SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c3a62f-5c11-c78c-e053-2a95a90a3a582023-10-23WarningsExact 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