H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC.]

H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC.]
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NDC 42421-115-11
Set ID 263bf96a-ddb9-45cc-8c80-8f69843d55c5
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Avobenzone, 3.0%
    Homosalate, 5.0%
    Octisalate, 5.0%
    Octocrylene, 4.0%

  • 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 product is 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: 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, cyclopentasiloxane, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, steareth-2, polyacrylamide, C13-14 isoparaffin, laureth-7, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-21, glycerin, caprylyl glycol, glyceryl caprylate, phenylpropanol, polymethyl methacrylate, silica, lecithin, soy isoflavones, polysorbate 80, acetyl hexapeptide-8, panthenol, persea gratissima (avocado) oil*, citrus aurantium bergamia (bergamot) fruit oil*, santalum album (sandalwood) oil*, citrus medica limonum (lemon) peel oil*, cedrus atlantica (cedarwood) bark oil*, pogostomon cablin (patchouli) oil*, myroxylon pereirae (balsam peru) oil*, dipteryx odorata bean extract*, vetiveria zizanoides root oil*, cinnamomum cassia oil*, elettaria cardamomum (cardamon) seed oil*, lavandula angustifolia (lavender) oil*, disodium EDTA, olea europaea (olive) fruit oil*, simmondsia chinensis (jojoba) seed oil*, aloe barbadensis leaf juice*, benzalkonium chloride, BHT, maris sal (dead sea mineral water), triethanolamine, opuntia streptacantha (cactus) stem extract*, phenoxyethanol.

    *Organic

  • Adverse Event Reporting:

    (866) 543-5125

  • Package/Label Principal Display Panel

    DEAD SEA SKIN CARE by H-E-B.
    PROTECT & CORRECT DAY CREAM
    BROAD SPECTRUM SPF15 SUNSCREEN
    Enriched with desert plants & Dead Sea minerals

    1.7 FL OZ (50mL)

    Dead Sea Skin Care Protect & Correct Day Cream Broad Spectrum SPF15 Sunscreen, with its unique formulation of desert plants, Dead Sea minerals and broad spectrum SPF15 sunscreen, will protect skin from harmful UV rays that cause premature skin aging. Leaves skin feeling softer, smoother with a healthy and radiant glow.

    For centuries the Dead Sea, the lowest place on earth, has hosted a rich reservoir of bio-sea minerals known for their exceptional beautifying and nourishing properties.

    We have taken the uniqueness of both the Dead Sea and desert plants to bring you a line of products specially formulated with time-proven goodness and health.

    Desert plants: Cactus, Jojoba, Aloe Vera & Olive deeply moisturize skin and provide skin nutrition.

    No animal by-products
    No animal testing
    pH balanced
    Paraben-free
    Fragrance-free

    Directions for Use: Smooth over cleansed face and neck every morning. Smooth in until completely absorbed.

    MADE WITH PRIDE AND CARE FOR H-E-B®,
    SAN ANTONIO, TEXAS 78204
    Made in Israel ZD115 1J C1

    WE BELIEVE THE HIGH QUALITY OF THIS H-E-B® PRODUCT MAKES IT AN OUTSTANDING VALUE. WE HOPE YOU’LL AGREE. IF NOT, WE’LL CHEERFULLY REFUND YOUR MONEY.
    THANKS FOR SHOPPING WITH US.

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    H-E-B DEAD SEA ORGANICS PROTECT AND PERFECT DAY BROAD SPECTRUM SPF15 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    SANDALWOOD OIL (UNII: X7X01WMQ5F)  
    LEMON OIL (UNII: I9GRO824LL)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    BALSAM PERU OIL (UNII: DIK0395679)  
    DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)  
    VETIVER OIL (UNII: 9M9P32M01L)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-115-111 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/10/2014
    Labeler - Emilia Personal Care Inc. (965445112)

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