Label: VEGAN COLLAGEN EVERY DAY- avobenzone, homosalate, octocrylene, and octisalate 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 June 22, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3%Sunscreen
    Homosalate 15%Sunscreen
    Octocrylene 10%Sunscreen
    Octyl Salicylate 5%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun.
  • Warnings

    For external use only.

    • Do not use on damaged or broken skin.

    • Stop use & ask a doctor if rash occurs.

    • When using this product, keep out of eyes.
    • Rinse with water to remove.

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Shake well before use.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply after swimming or sweating.
    • Reapply at least every 2 hours.
    • Sun protection measures. Spending time in the sun increases your risk of skin cancer & 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 10 a.m. - 2 p.m.
      -
      wear long-sleeve shirts, pants, hats & sunglasses.
    • Children under 6 months: ask a doctor.
  • Inactive ingredients

    Aqua, Butyloctyl Salicylate, Coconut Alkanes, Coco-Caprylate/Caprate, Aloe Barbadensis Leaf Juice, Glycerin, Hydrolyzed Jojoba Esters, Glyceryl Stearate, Glyceryl Stearate Citrate, Sodium Stearoyl Glutamate, Polyglyceryl-4 Isostearate, Stearic Acid, Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan, Hydrogenated Castor Oil, Sr-Hydrozoan Polypeptide-1 (Vegan Collagen), Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Flower Extract, Jasminum Officinale (Jasmine) Extract, Chamomilla Recutita (Matricaria) Flower Extract, Arnica Montana Extract, Squalane, Oryza Sativa (Rice) Starch, Biosaccharide Gum-1, Phenoxyethanol, Ethylhexylglycerin, Parfum1.

    1
    our scent blend with natural and/or essential oils
  • Other information

    Protect this product from excessive heat & direct sun.

  • Questions or comments?

    Call toll free 1-888-322-2466
    Pacifica Beauty LLC Portland, Oregon

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    PACIFICA®

    VEGAN
    COLLAGEN
    EVERY DAY LOTION

    broad spectrum
    SPF 30
    protection

    vegan collagen

    hyaluronic acid
    & aloe vera

    flower extracts

    100% VEGAN
    CRUELTY-FREE

    1.7 fl oz • 50 mL

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VEGAN COLLAGEN EVERY DAY 
    avobenzone, homosalate, octocrylene, and octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    SQUALANE (UNII: GW89575KF9)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61197-500-0050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/01/2020
    Labeler - Pacifica Beauty LLC. (058549421)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(61197-500)
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