Label: RENEWAL DAILY MOISTURIZER SENSITIVE SKIN- zince oxide 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 July 21, 2011

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  • ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 5.0%

    ZINC OXIDE 3.0%

  • PURPOSE

    SUNSCREEN

    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

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    Enter section text here

  • DIRECTIONS

    APPLY LIBERALLY ON FACE, NECK AND OTHER EXPOSED AREAS EVERY MORNING AFTER CLEANSING.  REAPPLY IF EXCESS PERSPIRATION OR PRODUCT WEARS OCCURS.  PERFECT ALONE OR UNDER MAKEUP OR OVER A SERUM.  FOR SUNSCREEN BENEFITS, APPLY PRIOR TO SUN EXPOSURE.

  • QUESTIONS/COMMENTS?

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, C12-15 ALKYL BENZOATE, CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES,  ETHYLHEXYL ISONONANOATE, STYRENE/ACRYLATES COPOLYMER, DIMETHICONE, SILICA, ETHYHEXYL HYDROXYSTEARATE, GLYCERIN, GLYCERYL STEARATE, CETYL ALCOHOL, PEG-100 STEARATE, ETHYLHEXYLGLYCERIN, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, ALUMINA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-75 STEARATE, PENTYLENE GLYCOL, BISABOLOL, CAPRYLYL GLYCOL, ISOHEXADECANE, CHLORPHENESIN, ALUMINUM STEARATE, DISODIUM EDTA, PPG-12/SMDI COPOLYMER, CETETH-20, STEARETH-20, DIPROPYLENE GLYCOL DIBENZOATE, TRIETHOXYCAPRYLYLSILANE, POLYSORBATE 60, PPG-15 STEARYL ETHER BENZOATE, BHT.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    RENEWAL DAILY MOISTURIZER SENSITIVE SKIN 
    zince oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3420-250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/21/2011
    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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