Label: SERUM CREMA BROAD SPECTRUM SPF20 SUNSCREEN- 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 January 18, 2019

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  • Active Ingredient

    Zinc Oxide (non-nano uncoated) 13.5%

  • 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

    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.

  • 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 & other sun protection measures including:
    •
    limit time in the sun, especially from 10am–2pm
    •
    wear long-sleeved shirts, pants, hats & sunglasses
    •
    use a water-resistant sunscreen if swimming or sweating
    •
    reapply at least every 2 hours
  • OTHER INFORMATION

    Protect this product from excessive heat & direct sunlight.

  • INACTIVE INGREDIENTS

    Argania Spinosa Kernel Oil* (Argan), Camellia Sinensis (Green Tea) Seed Oil*, Carthamus Tinctorius (Safflower) Seed Oil*, Cera Alba (Beeswax)*, Glycerin*, Glycyrrhiza Glabra (Licorice) Root Extract, Haematococcus Pluvialis Extract (Astaxanthin derived from Plankton), Helianthus Annuus (Sunflower) Seed Oil*, Iron Oxides (CI 77491) & (CI 77492), Jojoba Esters, Persea Gratissima (Avocado) Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E). *denotes certified organic

  • Package/Label Principal Display Panel

    VIVE SANA
    ORGANIC SUNCARE

    SERUM CREMA
    PREPARE-DEEPLY NOURISHING ARGAN
    PROTECT-NON-NANO UNCOATED ZINC
    REBUILD-GREEN TEA & RED RASPBERRY
    IMPROVE-PLANKTON & LICORICE ROOT
    BROAD SPECTRUM
    -SPF 20-
    SHEER BRIGHTENING FINISH
    100% NATURAL

    NET WEIGHT 2 FL. OZ / 59 ML

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    SERUM CREMA  BROAD SPECTRUM SPF20 SUNSCREEN
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71556-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ROSEMARY (UNII: IJ67X351P9)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71556-200-011 in 1 CARTON07/10/2017
    159 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/10/2017
    Labeler - Pure on Purpose, LLC (080668430)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(71556-200)
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