Label: ANTI-AGING VITAMIN COMPLEX 7-IN-1 BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, octisalate, octocrylene cream

  • 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 September 27, 2013

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

  • 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: 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
    SPF 15 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)

    For those who are concerned about exposure to the sun and the main cause of premature visible aging, this fragrance-free, color-free facial moisturizer provides 7 anti-aging treatments in 1 formulation, plus extra protection against sun damage.

    1. Line Reduction: Diminishes the appearance of fine lines and wrinkles
    2. Moisturizing Nourishment: for a healthy and radiant glow
    3. Tone Improvement: Evens out skin color, reducing the appearance of age spots
    4. Gentle Exfoliation: Smoothes and evens out skin texture
    5. Refinement of Pores: Minimizes the appearance of pores
    6. Defense Against Free Radicals: Prevents damage to skin's surface
    7. Delicate Lifting: Hydrates the skin for a firmer appearance

    RESULTS: Younger-looking skin that appears more resilient to aging.

    Directions for Uses:
    Apply liberally on face and neck as often as necessary each day to help protect your skin from harmful UV rays while keeping skin soft and smooth. Gentle enough for every day use. Designed to replace your moisturizer and specially skin care products.

    This Exclusive Formulation Is:

    • Dermatologist Tested
    • Non-Comedogenic (won't clog pores)
    • Color and Fragrance Free
    • Oil Free
    • Fast Absorbing

    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

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    ANTI-AGING VITAMIN COMPLEX 7-IN-1 BROAD SPECTRUM SPF15 SUNSCREEN 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-693
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    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 TETRAISOPALMITATE (UNII: 47143LT58A)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-693-111 in 1 CARTON
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/15/2013
    Labeler - American Sales Company (809183973)