Label: PURISTICS TOTALLYAGELESS SPF 15 DAILY ANTI-AGING- octisalate, zinc oxide 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 December 1, 2011

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  • Active ingredients

    Octisalate 5%
    Zinc oxide 3.75%

  • 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 the 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 PoisonControlCenter right away.

  • Directions

    • gently smooth over cleansed face and neck daily
    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 from excessive heat and direct sun
  • Inactive ingredients

    purified water, caprylic/capric triglyceride (coconut/palm), squalane (olives), glycerin, tapioca starch, sucrose distearate (sugar), sucrose stearate, sunflower seed wax, palm butter, hydrogenated soybean oil, citric acid, lauric acid (coconut), beeswax, rice bran wax, allantoin, rosewood oil, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), hyaluronic acid (natural skin conditioner), saccharomyces/hexapeptide-11 ferment extract (natural collagen builder), polylysine (natural preservative), honeysuckle extract (natural preservative)

  • Principal panel display

    new!

    the power of pure®

    puristics®

    totallyageless®

    SPF 15

    Daily Anti-Aging

    SUNSCREEN LOTION

    Broad Spectrum SPF 15

    hydrates for younger looking skin

    1.7 FL OZ (50 ml)

    Pure. Safe. Effective.

    naturally preserved & fragrance free 

    no parabens, phthalates or sulfates 

    no animal testing 

    Learn more at www.puristics.com

    Puristics Totally Ageless SPF 15 Daily Anti-Aging Sunscreen Lotion is unique because it starts with purity and ends with purity. There are no harmful chemicals, fragrances or toxins added at any step in the process. Powered by a naturally occurring peptide complex, our vitamin enriched product has been proven to be safe and effective.

    hydrates for younger looking skin

    hypoallergenic

    free from harmful chemicals

    ©2011 Distributed by
    Scerene Healthcare, Inc.
    Peapack, NJ 07977
    1-877-267-0519

    13010511

    Actual Size

    discover the power of pure

    At Puristics, we believe in the Power of Pure - anti-aging skin care products without any potentially harmful chemicals that could seep into your skin. We’ve created our products using the latest science to unleash the power of naturally derived ingredients, combining them in unique ways to maximize their effectiveness without compromising purity.

    Pure. Safe. Effective.

    Label
  • INGREDIENTS AND APPEARANCE
    PURISTICS TOTALLYAGELESS SPF 15 DAILY ANTI-AGING  
    octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76026-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mL  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide3.75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-chain Triglycerides (UNII: C9H2L21V7U)  
    Squalane (UNII: GW89575KF9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Starch, Tapioca (UNII: 24SC3U704I)  
    Sucrose Distearate (UNII: 96QS1D0T15)  
    Sucrose Stearate (UNII: 274KW0O50M)  
    Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)  
    Elaeis Guineensis Fruit Butter (UNII: UYH3R74N56)  
    Hydrogenated Soybean Oil (UNII: A2M91M918C)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Lauric Acid (UNII: 1160N9NU9U)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Rice Bran (UNII: R60QEP13IC)  
    Allantoin (UNII: 344S277G0Z)  
    Rosewood Oil (UNII: F2522O5L7B)  
    .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronic Acid (UNII: S270N0TRQY)  
    Lonicera Caprifolium Flower (UNII: 5N1WD9784U)  
    Lonicera Japonica Flower (UNII: 4465L2WS4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76026-304-171 in 1 BOX
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - Scerene Healthcare, Inc. (832688209)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioZone Laboratories, Inc.555564293MANUFACTURE
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