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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.22821e9d-eb3a-4e21-87ae-737b251255342024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Shimmer SunscreenZINC OXIDEMeadow and Bark14bbd191-ef3b-628e-e063-6294a90a1e662024-04-03WarningsExact identifier
application number: M020
Meadow and Bark SPF 45 Mineral Sport SunscreenZINC OXIDEMeadow and Bark1494c0e1-97f5-411c-e063-6294a90ab2ca2024-04-03WarningsExact identifier
application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBEL STAR S Aea3a0e07-a277-48c8-e053-2a95a90a172f2024-04-02WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodySprayOCTOCRYLENE, OCTISALATE, AVOBENZONESol de Janeiro USA, Inc1520a151-70c4-8699-e063-6294a90adc6b2024-04-02WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer075efd92-1632-d8c8-e063-6294a90a8c1a2024-04-02WarningsExact identifier
application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30ZINC OXIDEGood Molecules, LLCe9596344-a7ab-f582-e053-2a95a90a55252024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum MinisHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.f5c4186e-f167-40fc-b308-0b4406d3ec552024-04-02WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HolidayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.95d9a485-7418-437a-8e7d-ebcc090883562024-04-02WarningsExact identifier
application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30ZINC OXIDEAllure Labs14cff1a3-89b9-f4da-e063-6394a90a1a412024-03-29WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral SunscreenZINC OXIDELemongrass Spa Products, LLC14bcbaf9-76a5-f8ba-e063-6294a90a91f62024-03-28WarningsExact identifier
application number: M020
Rubber Ducky SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarefree Skincare Ventures, LLC14bd5cf9-423e-53a8-e063-6394a90a29f12024-03-28WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50ZINC OXIDEALLI LLC25a88843-078b-4589-b8b7-ea439ba6a15b2024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 BodyLotionZINC OXIDESOL DE JANEIRO USA, INC.14a85a88-c9a2-94ea-e063-6394a90a4e142024-03-27WarningsExact identifier
application number: M020
Rio Radiance SPF 50 Body OilOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESOL DE JANEIRO USA, INC.14acf152-e72a-debb-e063-6294a90a243d2024-03-27WarningsExact identifier
application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
application number: M020
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
application number: M020
Eminence Daily Defense Tinted SPFZINC OXIDEEminence Organic Skin Care14854bad-317e-154d-e063-6294a90a884f2024-03-25WarningsExact identifier
application number: M020
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact 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