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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCaa937596-2378-469f-a0e1-9700044e83b32025-03-20WarningsExact identifier
application number: M020
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDEThe Creme Shop30a4280b-4a9f-4c18-e063-6394a90a85e62025-03-18WarningsExact identifier
application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45ZINC OXIDEEai-jr 286, Inc30a5ec14-63d7-e678-e063-6294a90abb572025-03-18WarningsExact identifier
application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc88e44da-0b0e-4744-8b4b-4d9d418f29d72025-03-18WarningsExact identifier
application number: M020
MDP UV BIO SUNSCREENZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATESKINIDEA CO., LTD3087771e-2ab8-2198-e063-6294a90a37d42025-03-17WarningsExact identifier
application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.2b38da59-b83e-4285-e063-6294a90ac6a72025-03-17WarningsExact identifier
application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
application number: M020
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact 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