Label: CAREONE 7-IN-1 ANTI-AGING VITAMIN- avobenzone, octisalate and octocrylene 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 11, 2012

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  • Active ingredient

    Avobenzone 3.0

    Octisalate 5.0%

    Octocrylene 8.0%

  • Purpose

    Sunscreen

  • Uses

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

    For external use only.

  • Do not use on

    • damaged or broken skin.
  • When using this product

    • keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor

    • if rash occurs.
  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months of age: ask a doctor
    • 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 value 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-sleeved shirts, pants, hats and sunglasses
  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    water, glycerin, isopropyl isostearate, boron nitride, sodium carboxymethyl beta-glucan, polyacrylamide, C13-14 isoparaffin, laureth-7, cetyl alcohol, stearyl alcohol, cyclopentasiloxane, dimethiconol, dimethicone, cetearyl alcohol, cetearyl glucoside, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, sorbitan stearate, panthenol (pro-vitamin B5), behenyl alcohol, tocopheryl acetate (vitamin E), benzyl alcohol, disodium EDTA, PEG-100 stearate, stearic acid, ascorbyl tetraisopalmitate, magnesium aspartate, zinc gluconate, copper gluconate, calcium gluconate, dihydroxyacetone

  • Package/Label Principal Display Panel

    CareOne® anti-aging vitamin complex
    7-in-1 broad spectrum SPF15 sunscreen

    fragrance free

    7 anti-aging treatments in 1 vitamin and antioxidant moisturizer
    + broad spectrum SPF15 protection for younger-looking skin

    1.7 FL OZ (50 mL)

    DISTRIBUTED BY:
    AMERICAN SALES COMPANY
    4201 WALDEN AVENUE
    LANCASTER, NY 14086
    www.care1.info
    © 2012 S&S Brands, Inc.
    Quality guaranteed or your money back.
    Manufactured in Israel
    2F692 D4 C2

    Principal display panel - carton label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    CAREONE 7-IN-1 ANTI-AGING VITAMIN 
    avobenzone, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-869
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-869-241 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/11/2012
    Labeler - American Sales Company (809183973)
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