Label: GET MR SKINCARE DAILY PROTECTION SPF30 SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 52261-7700-0, 52261-7700-1, 52261-7700-2, 52261-7700-3, view more
    52261-7700-4
  • Packager: Cosco International, 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 January 24, 2022

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  • Drug Facts

    Active Ingredient...........................Purpose

    Zinc Oxide 18.75%..........................Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun
  • Warnings

    • For external use only

    • Do not use on damaged or borken skin

    • When using this product keep out of eyes. Rinse with water to remove

    • Stop use and ask a physician if rash occurs

    • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply liberally to face, neck, and ears
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every two hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a physician 
  • Inactivve Ingredients

    ALMOND OIL, ALPHA-TOCOPHEROL ACETATE, ASCORBIC ACID, CAPRYLYL/CAPRYL OLIGOGLUCOSIDE, CAPRYLYL GLYCOL, CETYL ALCOHOL, COCOYL CAPRYLOCAPRATE, DOCOSANOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, GLYCERIN, GLYCERYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED JOJOBA OIL, HYDROGENATED RAPESEED OIL, HYDROXYETHYL CELLULOSE, LACTOBIONIC ACID, MEDIUM-CHAIN TRIGLYCERIDES, NIACINAMIDE, OCTYLDODECANOL, PEG-8 DIMETHICONE, PENTYLENE GLYCOL, PHENOXYETHANOL, POLYGLYCERYL-6 DISTEARATE, POLYHYDROXYSTEARIC ACID, SAPONARIA OFFICINALIS LEAF, SILICON DIOXIDE, SODIUM CHLORIDE, SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA, VALINE, VITAMIN A PALMITATE, WATER, YELLOW WAX

  • Other Information

    • Protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-866-438-6712

  • PRINCIPAL DISPLAY PANEL

    sachet label

  • PRINCIPAL DISPLAY PANEL

    1oz bottle label

  • PRINCIPAL DISPLAY PANEL

    1oz bottle carton

  • PRINCIPAL DISPLAY PANEL

    3oz tube label

  • PRINCIPAL DISPLAY PANEL

    2022 1oz tube carton2022 1oz tube label

  • INGREDIENTS AND APPEARANCE
    GET MR SKINCARE DAILY PROTECTION SPF30 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-7700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1875 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    VALINE (UNII: HG18B9YRS7)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SAPONARIA OFFICINALIS LEAF (UNII: 3988313MM7)  
    LACTOBIONIC ACID (UNII: 65R938S4DV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-7700-00.002 kg in 1 PACKET; Type 0: Not a Combination Product10/01/2020
    2NDC:52261-7700-21 in 1 BOX10/01/2020
    2NDC:52261-7700-10.030 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:52261-7700-30.090 kg in 1 TUBE; Type 0: Not a Combination Product01/24/2022
    4NDC:52261-7700-41 in 1 CARTON01/25/2022
    40.030 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2020
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-7700) , label(52261-7700) , pack(52261-7700)
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