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

.ALPHA.-TOCOPHEROL; ANHYDROUS CITRIC ACID; ASCORBIC ACID; ASCORBYL PALMITATE; AVOBENZONE; BEMOTRIZINOL; BUTYLATED HYDROXYTOLUENE; BUTYLENE GLYCOL; C20-22 ALCOHOLS; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CHLORPHENESIN; DIMETHICONE; FRAGRANCE 13576; GLYCERIN; LINOLEIC ACID; LINOLENIC ACID; OCTINOXATE; OCTISALATE; OCTOCRYLENE; PHENOXYETHANOL; POLY(METHYL METHACRYLATE; 450000 MW); POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL; SILICON DIOXIDE; TITANIUM DIOXIDE; TROMETHAMINE; WATER

Active strength

.006; .00025; .00025; .00125; 1.8; 1.45; .0018; 2.5; .3375; .075; .025; .1; 1.25; .3; .005; .49725; .00275; 3.5982; 1.8; 1.8; .35; 2.1; .14225; 2.5; .575; .425; .22; 27.55 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; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/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