Home NDC 83021-551 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 Ingredient Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE .025 g/50mL GLYCERIN .005 g/50mL LINOLENIC ACID .00275 g/50mL TROMETHAMINE .22 g/50mL OCTOCRYLENE 1.8 g/50mL BUTYLATED HYDROXYTOLUENE .0018 g/50mL PROPYLENE GLYCOL 2.5 g/50mL WATER 27.55 mL/50mL FRAGRANCE 13576 .3 g/50mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) .075 g/50mL .ALPHA.-TOCOPHEROL .006 g/50mL POLY(METHYL METHACRYLATE 2.1 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 ACID 1.8 g/50mL OCTISALATE 1.45 g/50mL BEMOTRIZINOL 1.25 g/50mL DIMETHICONE 3.5982 g/50mL OCTINOXATE 2.5 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.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83021-551-50 AnubisMed 50 mL in 1 BOTTLE CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-551 ANUBISMED (SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION) CREAM [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230906_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 97 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sei Bella CC Brightening Creme Fair OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 6892952a-d032-30bf-e053-2a91aa0a3bba 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium Tan OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4ed34-f492-67a6-e053-2a91aa0a0428 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen SUNSCREEN Melaleuca Inc. 1f1d1575-cf37-5d66-e063-6394a90ab2a3 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Daily Hydration AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc c9bb7d33-783b-4cbb-a130-91f92d4cc137 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e5326-73c3-9fa8-e053-2a95a90aae9d 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e3f45-8e6f-6a3f-e053-2995a90a17d2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Deep 550 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e31a82-0cd0-5a1a-e053-2991aa0a33f8 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2dfaa-d173-e6a9-e053-2a91aa0a4663 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 300 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c583-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30231-4fba-35d4-e053-2991aa0a33cb 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 440 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-5640-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-564f-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 320 C TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c596-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e20c57-7b30-4e96-e053-2991aa0aab3e 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Pina Colada AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 16d0d2d2-b9c4-4491-8d8a-815843d342e8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Mountain Mint AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 326d9623-0e67-43bd-83f8-ee7dfa3bdbe8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Vanilla Bean AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Mineral Plus Sunscreen with Zinc Oxide OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5% Melaleuca Inc. 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Daily Hydration AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc 798cbf7f-b93d-49c8-b1c1-216486e57ea5 2025-12-31 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83021-551-50 83021055150 50 mL in 1 BOTTLE (83021-551-50) 50 ml 2022-10-15 2027-04-29 No No Current