Label: CLEAR CLEAR ZINC SOLAR PROTECTION SPF 30- zinc oxide cream

  • 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 8, 2021

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

View All Sections
  • ACTIVE INGREDIENT

    Zinc Oxide: 17%

  • PURPOSE

    Purpose:

    Suncreen

  • INDICATIONS & USAGE

    Uses: Help prevent sunburn

  • WARNINGS

    Warnings: For external use only

  • DO NOT USE

    Do not use on damged or broken skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swalloed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Massage into skin with fingertips and reapply as needed. Avoid eye area while applying.

  • INACTIVE INGREDIENT

    Other Ingredients: Water (Aqua), Cyclopentasiloxane, Dimethicone/PEG10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crossploymer, Polyglyceryl-3 polydimethylsiloxyethyl Dimethicone, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Hexyl Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, C12-15 Alkyl Benzoate, Polyisobutene, Isododecane, Phenoxyethanol, Sodium Hyaluronate, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Mica, Aloe Barbadensis Leaf extract, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Leaf Extract, Silica

  • PRINCIPAL DISPLAY PANEL

    Physicians' Aesthetic Research, Inc. Distr.

    San Clemente, CA 92672 . Made in U.S.A. www.lucrece.com

    IMGLUCCZSPSPF30

  • INGREDIENTS AND APPEARANCE
    CLEAR CLEAR ZINC SOLAR PROTECTION SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MICA (UNII: V8A1AW0880)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4109-171 g in 1 TUBE; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/04/2017
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4109)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!