EARTH AND VINE BB BROAD SPECTRUM SPF 15 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [EMILIA PERSONAL CARE INC.]

EARTH AND VINE BB BROAD SPECTRUM SPF 15 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [EMILIA PERSONAL CARE INC.]
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NDC 42421-419-12
Set ID fbd287cf-a557-42ab-a530-9aee849c068d
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Octinoxate, 4.0%

    Titanium Dioxide, 2.1%

  • 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
    Reapply at least every 2 hours
    Use 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 the product in this container from excessive heat and direct sun
  • Inactive ingredients

    water, talc, C12-15 Alkyl benzoate, caprylic/capric triglyceride, potassium cetyl phosphate, cyclopentasiloxane, glyceryl myristate, isononyl isononanoate, behenyl alcohol, mineral oil, glycerin, propylene glycol, microcrystalline cellulose, cellulose gum, phenoxyethanol, ethylhexylglycerin, malus domestica fruit cell culture, xanthan gum, lecithin, nylon-12, triethanolamine, ammonium acryloyldimethyltaurate/VP copolymer, iron oxides, fragrance, butylene glycol, allantoin, caffeine, ascorbic acid, disodium EDTA, tocopheryl acetate (vitamin E), chamomilla recutita (matricaria) flower extract, persea gratissima (avocado) oil, cucumis sativus (cucumber) fruit oil, ginkgo biloba leaf extract, butyrospermum parkii (shea butter), simmondsia chinensis (jojoba) seed oil, BHT, camellia sinensis leaf extract, hyaluronic acid.

  • Package/Label Principal Display Panel

    Earth & Vine
    AGE-DEFYING SKINCARE

    SKIN
    ILLUMINATOR
    BB CREAM
    SPF 15

    Brightens & evens skin tone
    Formulated with powerful antioxidants
    Broad Spectrum SPF15
    Light/Medium skin tone
    Enhanced with Nutriplex™
    a skin nutrition complex

    2.5 fl oz
    75 mL

    Return your skin’s appearance to its original radiant self with Earth & Vine™ Skin Illuminator BB Cream. This BB Cream combines apple stem cells with broad spectrum SPF15 and additional anti-aging ingredients to awaken skin, even skin tone and brightens for smooth, natural looking skin

    Directions:
    Apply liberally 15 minutes before sun exposure. Reapply every 2 hours. Use water resistant sunscreen if swimming or sweating.
    Children under 6 months: Ask a doctor

    How Can Apples Deliver Beautiful Skin?

    Earth & Vine™ is a collection of skincare products uniquely formulated with the stem cells of Uttwiler Spätlauber, a rare Swiss apple with origins dating to the mid-18th century. Long known for its ability to be stockpiled without withering or showing “signs of aging.” Today, this exceptional gift of nature is recognized for its ability to maintain the vibrancy and freshness of skin. Treat your skin with “an apple a day” to awaken dormant skin cells, and to combat chronological aging of the skin.

    Earth & Vine™ is a collection of skin care products that are uniquely formulated to harness the power of fruit stem cells – nature’s greatest weapon against the aging process. Apple stem cells which are known for their anthocyanins – powerful antioxidants that help protect skin from UV radiation, premature photo-aging, oxidative stress. When blended with other organic anti-aging ingredients, skin looks naturally younger by diminishing the appearance of fine lines and wrinkles, evens and brightens skin tone, and clarifies the complexion.

    Nutriplex,™ our exclusive complex of a powerful, proprietary blend of the earth’s greatest nutrients and botanicals form a nutritious defense against the aging process.

    Rare Apple Stem Cells – for anti-aging & anti-wrinkles
    Chamomile – soothes and revitalizes skin
    Green Tea – contains anti-inflammatory properties that slow signs of aging
    Powerful Moisturizers including Shea Butter & Jojoba Oil to nourish and hydrate skin

    Visit us at
    www.earthandvineskincare.com

    Made in Israel
    Distributed by:
    Emilia Personal Care
    5890 Sawmill Road, Suite 230
    Dublin, OH 43017

    WD418 83 C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    EARTH AND VINE BB BROAD SPECTRUM SPF 15 SUNSCREEN 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-419
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MYRISTATE (UNII: 6992Y81827)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    APPLE (UNII: B423VGH5S9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    NYLON-12 (UNII: 446U8J075B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
    GINKGO (UNII: 19FUJ2C58T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-419-121 in 1 CARTON
    175 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 finalpart35209/01/2014
    Labeler - Emilia Personal Care Inc. (965445112)

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