Label: RITE AID RENEWAL SUNSCREEN- ensulizole lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 21, 2011

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  • ACTIVE INGREDIENT

    ENSULIZOLE  2.0%, OCTINOXATE  7.5%, OCTOCRYLENE  7.5%, ZINC OXIDE  1.9%

  • PURPOSE

    SUNSCREEN

  • USES

    TO HELP MOISTURIZE, RELIEVE AND PROTECT SKIN

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IF IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL IMMEDIATELY

  • DIRECTIONS

    APPLY LIBERALLY ON FACE, NECK AND OTHER EXPOSED AREAS EVERY MORNING AFTER CLEANSING. PERFECT ALONE OR UNDER MAKEUP. FOR SUNSCREEN BENEFITS, APPLY PRIOR TO SUN EXPOSURE.

  • QUESTIONS OR COMMENTS

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, GLYCERIN,CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, PEG-100 STEARATE, GLYCERYL STEARATE, CETEARYL ALCOHOL, TRIETHOXYCAPRYLSILANE, TRIETHANOLAMINE, BEHENYL ALCOHOL, SODIUM HYALURONATE, CYCLOHEXASILOXANE, CODIUM TOMENTOSUM, BHT, TOCOPHEROL, CALCIUM PENTOTHENATE, BISABOLOL, DICETYL PHOSPHATE, CETETH-10 PHOSPHATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, TRIMETHYLOLPROPANE TRIETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, BUTYLPARABEN, IRON OXIDES

  • LABEL COPY

    image of the label

  • INGREDIENTS AND APPEARANCE
    RITE AID RENEWAL  SUNSCREEN
    ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.9 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BEHENYL PHOSPHATE (UNII: 366D9UAY69)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    1,2-BUTANEDIOL (UNII: RUN0H01QEU)  
    TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    ANISACRIL (UNII: 5TB1FV429Z)  
    GUAR GUM (UNII: E89I1637KE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3410-250 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/21/2011
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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