FDA.reportPublic FDA data

AnubisMed

Product NDC
83021-551
11-digit product format
830210551
Labeler code
83021
Product ID
83021-551_049fca13-6920-d895-e063-6294a90a42da
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 50 Broad Spectrum Protection Fluid Emulsion
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-15
Marketing end
2027-04-29
Substance
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; GLYCERIN; LINOLENIC ACID; TROMETHAMINE; OCTOCRYLENE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; WATER; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); .ALPHA.-TOCOPHEROL; POLY(METHYL METHACRYLATE; 450000 MW); AVOBENZONE; TITANIUM DIOXIDE; PHENOXYETHANOL; POLYETHYLENE GLYCOL 400; LINOLEIC ACID; SILICON DIOXIDE; ANHYDROUS CITRIC ACID; ASCORBYL PALMITATE; ASCORBIC ACID; OCTISALATE; BEMOTRIZINOL; DIMETHICONE; OCTINOXATE; BUTYLENE GLYCOL; C20-22 ALCOHOLS; CHLORPHENESIN
Active strength
.025; .005; .00275; .22; 1.8; .0018; 2.5; 27.55; .3; .075; .006; 2.1; 1.8; .425; .35; .14225; .49725; .575; .00025; .00125; .00025; 1.8; 1.45; 1.25; 3.5982; 2.5; .3375; .1 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
Pharmacologic classes
Acidifying Activity [MoA], Allergens [CS], Anti-coagulant [EPC], Ascorbic Acid [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]
NDC exclude flag
No
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
AnubisMed

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.025 g/50mL
GLYCERIN.005 g/50mL
LINOLENIC ACID.00275 g/50mL
TROMETHAMINE.22 g/50mL
OCTOCRYLENE1.8 g/50mL
BUTYLATED HYDROXYTOLUENE.0018 g/50mL
PROPYLENE GLYCOL2.5 g/50mL
WATER27.55 mL/50mL
FRAGRANCE 13576.3 g/50mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED).075 g/50mL
.ALPHA.-TOCOPHEROL.006 g/50mL
POLY(METHYL METHACRYLATE2.1 g/50mL
450000 MW)1.8 g/50mL
AVOBENZONE.425 g/50mL
TITANIUM DIOXIDE.35 g/50mL
PHENOXYETHANOL.14225 g/50mL
POLYETHYLENE GLYCOL 400.49725 g/50mL
LINOLEIC ACID.575 g/50mL
SILICON DIOXIDE.00025 g/50mL
ANHYDROUS CITRIC ACID.00125 g/50mL
ASCORBYL PALMITATE.00025 g/50mL
ASCORBIC ACID1.8 g/50mL
OCTISALATE1.45 g/50mL
BEMOTRIZINOL1.25 g/50mL
DIMETHICONE3.5982 g/50mL
OCTINOXATE2.5 g/50mL
BUTYLENE GLYCOL.3375 g/50mL
C20-22 ALCOHOLS.1 g/50mL
CHLORPHENESIN

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 27 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0A5MM307FCInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
0RBV727H71Internal UNII lookup
023C2WHX2VInternal UNII lookup
5A68WGF6WMInternal UNII lookup
1P9D0Z171KInternal UNII lookup
6DC9Q167V3Internal UNII lookup
059QF0KO0RInternal UNII lookup
5EM498GW35Internal UNII lookup
71DD5V995LInternal UNII lookup
H4N855PNZ1Internal UNII lookup
G63QQF2NOXInternal UNII lookup
15FIX9V2JPInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
B697894SGQInternal UNII lookup
9KJL21T0QJInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
XF417D3PSLInternal UNII lookup
QN83US2B0NInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e99d92c4-8768-9c0a-e053-2a95a90a609eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-551-50AnubisMed50 mL in 1 BOTTLECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-551ANUBISMED (SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_e99d92c4-8768-9c0a-e053-2a95a90a609e.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 66 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
application number: M020
Touch in SOL No Poreblem Airbrushed PrimerOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBONNE Co., Ltd4685ff24-0bb0-3502-e063-6394a90abfee2026-01-29WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Incc7650d20-7cb9-4861-8a30-cf4a9cd424e92026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEAldi, Inc32c0613e-0f5a-47f5-b2f3-f32ae07cbc762026-01-29Warnings, Adverse reactionsExact identifier
application number: M020
Vacation Original Coconut SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.a9a0b558-b8e6-44ea-9b57-6938837a04fb2026-01-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-551-508302105515050 mL in 1 BOTTLE (83021-551-50) 50 ml2022-10-152027-04-29NoNoCurrent