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 68 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact identifier
application number: M020
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact 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