Label: PERFECT SHIELD REJUVE SUNSCREEN 100- zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 May 30, 2018

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  • Active Ingredient

    Zinc Oxide (9%) ------------------------------- Sunscreen
    Octinoxate (6%) ------------------------------- Sunscreen
    Octisalate (4%) -------------------------------- Sunscreen
    Titanium Dioxide (2%) ----------------------- Sunscreen

  • Purpose

    Sunscreen

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

  • Do not use when

    skin is red, inflamed, irritated, or painful

  • Directions

    Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection.

    Apply liberally 15 minutes before sun exposure.

    Reapply at least every 2 hours.

    Use a water-resistant sunscreen if swimming or sweating.

    Children under 6 months of age: ask a doctor

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    Helps prevent sunburn

  • Inactive Ingredients

    WATER, CYCLOPENTASILOXANE, GLYCERIN, PROPANEDIOL, HOMOSALATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE, 1,2-HEXANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, SORBITAN CAPRYLATE, FRAGRANCE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, DIPROPYLENE GLYCOL, CERAMIDE NP, SUCROSE STEARATE, SODIUM CITRATE, TOCOPHEROL, CHOLESTEROL, STEARIC ACID, CHOLESTERYL MACADAMIATE, PALMITIC ACID, BUTYLENE GLYCOL, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN, DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE, PALMITOYL TRIPEPTIDE-5, OLIGOPEPTIDE-1

  • Perfect Shield Rejuve Sunscreen 100

    Perfect shield

  • INGREDIENTS AND APPEARANCE
    PERFECT SHIELD REJUVE SUNSCREEN 100 
    zinc oxide, octyl methoxycinnamate, octyl salicylate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.5 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 21.14 g  in 50 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52554-1116-21 in 1 CARTON05/30/2018
    1NDC:52554-1116-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/30/2018
    Labeler - CMS LAB Inc (557795012)
    Registrant - CMS LAB Inc (557795012)
    Establishment
    NameAddressID/FEIBusiness Operations
    CMS LAB Inc557795012relabel(52554-1116)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(52554-1116)