FDA.reportPublic FDA data

Anubis Barcelona Protective Line

Product NDC
83021-686
11-digit product format
830210686
Labeler code
83021
Product ID
83021-686_0452914b-b325-8a71-e063-6394a90a92de
Type
HUMAN OTC DRUG
Nonproprietary name
Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-02
Marketing end
2028-03-09
Substance
OCTINOXATE; TITANIUM DIOXIDE; CHLORPHENESIN; OCTISALATE; BUTYLENE GLYCOL; PROPYLENE GLYCOL; POLY(METHYL METHACRYLATE; 450000 MW); WATER; SILICON DIOXIDE; BUTYLATED HYDROXYTOLUENE; DIMETHICONE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; C20-22 ALCOHOLS; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); TROMETHAMINE; BEMOTRIZINOL; POLYETHYLENE GLYCOL 400; ASCORBYL PALMITATE; PHENOXYETHANOL; OCTOCRYLENE; AVOBENZONE; LINOLENIC ACID; ASCORBIC ACID; TOCOPHEROL; LINOLEIC ACID; GLYCERIN
Active strength
3.5982; .425; .1; 1.8; 2.5; 2.5; 2.1; 27.55; .575; .0018; 1.25; .025; .3375; .3; .075; .22; 1.45; .14225; .00125; .35; 1.8; 1.8; .00275; .00025; .006; .49725; .005 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
Pharmacologic classes
Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [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
Anubis Barcelona Protective Line

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE3.5982 g/50mL
TITANIUM DIOXIDE.425 g/50mL
CHLORPHENESIN.1 g/50mL
OCTISALATE1.8 g/50mL
BUTYLENE GLYCOL2.5 g/50mL
PROPYLENE GLYCOL2.5 g/50mL
POLY(METHYL METHACRYLATE2.1 g/50mL
450000 MW)27.55 mL/50mL
WATER.575 g/50mL
SILICON DIOXIDE.0018 g/50mL
BUTYLATED HYDROXYTOLUENE1.25 g/50mL
DIMETHICONE.025 g/50mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.3375 g/50mL
C20-22 ALCOHOLS.3 g/50mL
FRAGRANCE 13576.075 g/50mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED).22 g/50mL
TROMETHAMINE1.45 g/50mL
BEMOTRIZINOL.14225 g/50mL
POLYETHYLENE GLYCOL 400.00125 g/50mL
ASCORBYL PALMITATE.35 g/50mL
PHENOXYETHANOL1.8 g/50mL
OCTOCRYLENE1.8 g/50mL
AVOBENZONE.00275 g/50mL
LINOLENIC ACID.00025 g/50mL
ASCORBIC ACID.006 g/50mL
TOCOPHEROL.49725 g/50mL
LINOLEIC ACID.005 g/50mL
GLYCERIN

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup
I670DAL4SZInternal UNII lookup
4X49Y0596WInternal UNII lookup
3XUS85K0RAInternal UNII lookup
6DC9Q167V3Internal UNII lookup
059QF0KO0RInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
1P9D0Z171KInternal UNII lookup
92RU3N3Y1OInternal UNII lookup
0A5MM307FCInternal UNII lookup
O4M0347C6AInternal UNII lookup
5EM498GW35Internal UNII lookup
71DD5V995LInternal UNII lookup
023C2WHX2VInternal UNII lookup
PWZ1720CBHInternal UNII lookup
B697894SGQInternal UNII lookup
QN83US2B0NInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec83846f-11c0-8f59-e053-2995a90ab9d2Available 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
83021-686-50Anubis Barcelona Protective Line50 mL in 1 BOTTLECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-686ANUBIS BARCELONA PROTECTIVE LINE (ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_ec83846f-11c0-8f59-e053-2995a90ab9d2.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 171 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Land Shark SPF 30 Tinted ZincZINC OXIDE AND TITANIUM DIOXIDETropical Seas, Inc.d1287899-f178-6124-e053-2a95a90a95a52025-11-04WarningsExact identifier
application number: M020
Naked Sundays BeautyScreen Peptide Foundation TintZINC OXIDENaked Sundays1a623dfc-a8fc-858b-e063-6294a90a9c112025-11-04WarningsExact identifier
application number: M020
Odacite Mineral Drops Sheer SunscreenZINC OXIDEOdacite303f3af6-631a-57a8-e063-6294a90addda2025-11-04WarningsExact identifier
application number: M020
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2392c772-c251-1597-e063-6394a90a52f22025-11-03WarningsExact identifier
application number: M020
Hawaiian Tropic everyday Active Sport Sunscreen SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care LLCdc7d0757-c8a2-7fdb-e053-2a95a90a52822025-11-03WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
application number: M020
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c23c754a-9441-0a05-e053-2995a90afc552025-11-02WarningsExact identifier
application number: M020
SPF 30 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%Geiss, Destin, & Dunn, Inca22c6359-435d-626b-e053-2a95a90ae0c62025-11-02WarningsExact identifier
application number: M020
Iris and Romeo Weekend SkinZINC OXIDEIris and Romeo0828a345-0178-1503-e063-6394a90a7d242025-10-31WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Bronze GlowZINC OXIDEIris and Romeo2abe1780-d1e6-a90a-e063-6294a90a64ee2025-10-31WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Warm GlowZINC OXIDEIris and Romeo0852977a-83e5-26cf-e063-6294a90ab3f92025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 205 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.055878ef-c671-4d65-9639-bda5a1dc30292025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 120 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b6b18a13-1f22-4061-91f5-852f7a487c032025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 100 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d7815651-6b14-41f6-90cd-0a5b0b4a12ac2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 140 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.59331429-5fe0-4671-aabd-ec20640dd3ee2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Fair 125 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.c6ef3b07-babf-401d-a241-4e81e162c9652025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 330 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.c6d4b851-bf09-4177-b473-a2378c55ceec2025-10-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-686-508302106865050 mL in 1 BOTTLE (83021-686-50) 50 ml2022-11-022028-03-09NoNoCurrent