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 293 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Care SPF 30 Facestick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONENaples Soap Co.1cfb91dc-178e-fd5d-e063-6394a90a53002024-07-11WarningsExact identifier
application number: M020
the beach people SPF 15ZINC OXIDEThe Beach People United LLC60c97b25-a23d-4f8f-bc20-0a312cbcde0e2024-07-11WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-COCTINOXATE, ZINC OXIDEBEL STAR S A1cec29ae-d402-0ee7-e063-6394a90a0a892024-07-10WarningsExact identifier
application number: M020
5298 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties667dccd6-5047-4beb-b2f0-0b8d8d79aa012024-07-10WarningsExact identifier
application number: M020
5283 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties3a06bb05-5965-4d7d-a299-3d48b163c6042024-07-10WarningsExact identifier
application number: M020
5281 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialties86fc4539-e1c5-4d0f-a418-f48729cb2b202024-07-10WarningsExact identifier
application number: M020
5299 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3db6bd8-cc6f-4af5-809d-95fb05f6732f2024-07-10WarningsExact identifier
application number: M020
5407 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEInnovation Specialtiesf3f86164-2a2e-4f1f-a562-c1ff6cf503222024-07-10WarningsExact identifier
application number: M020
LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.1bbf3712-b59d-cf6d-e063-6294a90af9b72024-07-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd1cbcf8a6-0e83-f759-e063-6394a90ac14d2024-07-08WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 BANANA SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5f02688-cb8a-4d9b-e053-2995a90ad1ba2024-07-08WarningsExact identifier
application number: M020
HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Ba5ef831e-7c28-7c85-e053-2995a90a9e022024-07-08WarningsExact identifier
application number: M020
Equaline Sport Continuous Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENESUPERVALU INC.1cc23322-2570-75ab-e063-6394a90ad2892024-07-08WarningsExact identifier
application number: M020
Equaline Zinc Oxide Sunscreen Stick SPF 50ZINC OXIDEUnited Natural Foods, Inc. dba UNFI1cc27f99-82f3-7aee-e063-6294a90a6f372024-07-08WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a8f5d5-d3c7-4a6f-e063-6294a90a94e32024-07-02WarningsExact identifier
application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip BalmZINC OXIDEElemental Herbs, Inc.fdf17ffa-681b-2809-e053-6394a90a5b6e2024-07-02WarningsExact identifier
application number: M020
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
application number: M020
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact 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