Label: DAY C- avobenzone octinoxate oxybenzone cream

  • NDC Code(s): 63550-120-03
  • Packager: Kamins Dermatologics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 10, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients:


    AVOBENZONE 2 %



    OCTINOXATE 7 %


    OXYBENZONE 5 %

  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • INDICATIONS & USAGE

    This light weight, non-greasy day cream preserves your skin with a healthier protective shield, essential nutrients and continuous moisture release suited to a multitude of daytime environmental conditions. Our Bio-maple technology helps fight the look of wrinkles, moisturizes and provides radiance throuhout the day. A perfect primer for mak-up. For maximum benefits, may be reapplied over make-up as often as needed. Also useful for soothing post-microdermabrasion skin.


    Uses

    helps prevent sunburn

    higher SPF gives more sunburn protection

    provides moderate protection against sunburn

  • WARNINGS

    Warnings

    For external use only.

    When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    If swallowed, seek medical assistance or contact a Poison Control Center immediately.



    Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.





  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed. reapply after swimming, washing/towel drying or perspiring heavily.

    Children under 6 months of age: ask a doctor.




  • INACTIVE INGREDIENT

    Inactive ingredients:

    aqua/water/eau, glyceryl stearate SE, soluble collagen, butylene glycol, acer saccharum (maple isolate), cetyl alcohol, ceteareth-12, coco-caprylate/caprate, squalane, magnesium aluminum silicate, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, PEG-16 soy sterol, dimethicone, polysorbate 80, prunus armeniaca (apricot) kernel oil, retinyl palmitate, tocopheryl acetate, sodium hydroxide, citric acid, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance. Contains oxybenzone

  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    DAY CREAM SPF15

    50mL / 1.7 fl.oz

    DIN 0246708

    Day Cream SPF15 front panel image

  • INGREDIENTS AND APPEARANCE
    DAY C 
    avobenzone octinoxate oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    SQUALANE (UNII: GW89575KF9)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-120-0350 g in 1 BOX; Type 0: Not a Combination Product10/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2003
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-120) , pack(63550-120)