Label: DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene lotion

  • 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 October 2, 2023

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  • ACTIVE INGREDIENTS

    AVOBENZONE 3.0%

    HOMOSALATE 10.0%

    OCTISALATE 5.0%

    OCTOCTYLENE 7.0%

  • PURPOSE

    SUNSCREEN

  • USE

    • HELPS PREVENT SUNBURN
    • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
  • WARNINGS

    FOR EXTERNAL USE ONLY

    DO NOT USE ON DAMAGED OR BROKEN SKIN

    STOP USE AND ASK A DOCTOR IF RASH OCCURS.

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
    • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING
    • REAPPLY AT LEAST EVERY 2 HOURS
    • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
    • SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
          LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
          WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

  • STORAGE AND HANDLING

    • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
  • INACTIVE INGREDIENTS

    WATER, BUTYLENE GLYCOL, TRIBEHENIN PEG-20 ESTERS, ISOCETYL STEAROYL STEARATE, DIMETHICONE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, POLYETHYLENE, LAURETH-4, CAPRYLYL GLYCOL, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, PENTYLENE GLYCOL, PEG-100 STEARATE, GLYCERYL STEARATE, GLYCERIN, HYDROGENATED LECITHIN, ACYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SODIUM HYDROXIDE, ISOHEXADECANE, HEXYLENE GLYCOL, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, SODIUM ASCORBYL PHOSPHATE, PUNICA GRANATUM FRUIT EXTRACT, HYDROLYZED JOJOBA ESTERS, DISODIUM EDTA, ALLYL METHACRYLATES CROSSPOLYMER, POLYSORBATE 80, N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE, SODIUM HYALURONATE, YELLOW 5, RED 40.

  • QUESTIONS OR COMMENTS?

    CALL 1-866-984-1433

  • PRINCIPAL DISPLAY PANEL

    01b UC_Daily Shield SPF20_45mL

    0-Image_Daily Shield SPF-20_45mL

  • INGREDIENTS AND APPEARANCE
    DAILY SHIELD   BROAD SPECTRUM SPF 20 MOISTURIZER
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70626-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    LAURETH-4 (UNII: 6HQ855798J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALLYL METHACRYLATE (UNII: G2IG50653Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE (UNII: 5YX5BR41EQ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70626-202-511 in 1 BOX12/06/2020
    145 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/06/2020
    Labeler - ASPIRE BRANDS INC (832462811)
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