Label: PURISTICS TOTALLY AGELESS SPF 15 DAILY ANTI-AGING- 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 February 7, 2011

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

  • Active Ingredient

    Zinc oxide 7.5%

  • Directions

    Gently smooth over cleansed face and neck daily.

  • Warnings

    For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. Keep out of reach of children.

  • Principal Panel Display

    Label

    new!

    the power of pure™

    puristics™

    totallyageless™

    SPF 15

    Daily Anti-Aging

    LOTION

    chemical free UVA/UVB protection

    helps prevent premature skin aging

    hydrates for younger looking skin

    1.7 FL OZ (50 ml)

    Puristics Totally Ageless SPF 15 Daily Anti-Aging 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 and a natural mineral sunscreen, our vitamin enriched product has been proven to be safe and effective.

    helps prevent premature skin aging

    hydrates for younger looking skin

    hypoallergenic

    no harmful chemicals

    Directions for use: Gently smooth over cleansed face and neck daily.

    discover the power of pure.

    At Puristics, we believe in the Power of Pure. We think that everything that touches your skin should be pure – without any potentially harmful chemicals seeping in. So, we’ve created our products using the latest science to unleash the power of naturally derived ingredients. We’ve combined them in unique ways to maximize their effectiveness without compromising purity.

    Pure. Safe. Effective.

    naturally preserved & fragrance free

    no parabens, phthalates or sulfates

    no animal testing

    Learn more at www.puristics.com

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear. Keep out of reach of children.

    Sun Alert: UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in sun, wearing protective clothing and using a sunscreen.

    Active Ingredient: Zinc oxide 7.5%

    A special blend of (derivation/description): purified water, caprylic/capric triglyceride (coconut/palm), octyl palmitate (skin conditioner), squalane (olives), glycerin, sucrose distearate (sugar), sunflower seed wax, palm butter, hydrogenated soybean oil, tapioca starch, citric acid, lauric acid (coconut), sucrose stearate, beeswax, rice bran wax, allantoin, xanthan gum (fermented sugar), rosewood oil, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), sodium hyaluronate (natural skin conditioner), saccharomyces/hexapeptide-11 ferment extract (natural collagen builder), polylysine (natural preservative), honeysuckle extract (natural preservative)

    ©2010 Distributed by
    Scerene Healthcare, Inc.
    Peapack, NJ 07977
    1-877-267-0519

    13010210

  • INGREDIENTS AND APPEARANCE
    PURISTICS TOTALLY AGELESS SPF 15 DAILY ANTI-AGING  
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76026-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-chain Triglycerides (UNII: C9H2L21V7U)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Squalane (UNII: GW89575KF9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogenated Soybean Oil (UNII: A2M91M918C)  
    Starch, Tapioca (UNII: 24SC3U704I)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Lauric Acid (UNII: 1160N9NU9U)  
    Sucrose Stearate (UNII: 274KW0O50M)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Allantoin (UNII: 344S277G0Z)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Rosewood Oil (UNII: F2522O5L7B)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Lonicera Caprifolium Flower (UNII: 5N1WD9784U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76026-204-171 in 1 BOX
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/20/2010
    Labeler - Scerene Healthcare, Inc. (832688209)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioZone Laboratories, Inc.555564293MANUFACTURE