ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 (OCTISALATE, OCTOCRYLENE, AND AVOBENZONE) LOTION [ANDALOU NATURALS]

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  • ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 (OCTISALATE, OCTOCRYLENE, AND AVOBENZONE) LOTION [ANDALOU NATURALS]

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 (OCTISALATE, OCTOCRYLENE, AND AVOBENZONE) LOTION [ANDALOU NATURALS]
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NDC 55560-1811-1
Set ID 58fd7b0c-4b4b-4705-b325-49fbfbac889a
Category HUMAN OTC DRUG LABEL
Packager Andalou naturals
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octisalate 5.0%Sunscreen
    Octocrylene 5.0%Sunscreen
    Avobenzone 2.5%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 or irritation develops and lasts.
  • Directions

    • Daily, alone or under make-up.
    • Apply liberally 15-30 minutes before sun exposure and as needed.
    • Reapply at least every 2 hours.
    • Use water resistant sunscreen if swimming or sweating.
    • 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
    • Children under 6 months: ask a doctor.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Vegetable Glycerin, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil1, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Dimethicone, Lecithin, Tocopherol, Magnesium Ascorbyl Phosphate (Vitamin C), Resveratrol, Ubiquinone (CoQ10), Panthenol, Allantoin, Dipotassium Glycyrrhizinate (Licorice) Root Extract1, Laminaria Digitata (Kelp) Extract, Curcuma Longa (Turmeric) Root Extract1, Epilobium Angustifolium (Willow Herb) Extract, Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Sodium Hyaluronate, Rosa Canina (Rosehip) Fruit Oil1, Camellia Sinensis (White Tea) Leaf Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Flower Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil1

    1
    Certified Organic
    2
    Fair Trade Ingredients
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Questions

    Call (888) 898-6955 or visit www.Andalou.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals
    Novato, CA 94945 USA

  • PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

    NEW LOOK

    ANDALOU
    NATURALS

    NON
    GMO

    Ultra Sheer

    DAILY DEFENSE

    Facial Lotion
    SPF 18

    with Resveratrol Q10
    Youthful Vitality

    Broad Spectrum Protection

    FRUIT
    STEM
    CELL

    SCIENCE®

    AGE DEFYING

    2.7 fl oz e 80 mL

    PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 
    octisalate, octocrylene, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-1811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    APPLE (UNII: B423VGH5S9)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ACAI (UNII: 46AM2VJ0AW)  
    ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    VACCINIUM MYRTILLUS ANTHOCYANOSIDES (UNII: R911H793SU)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    RESVERATROL (UNII: Q369O8926L)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LICORICE (UNII: 61ZBX54883)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    TURMERIC (UNII: 856YO1Z64F)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    WHITE TEA (UNII: O0M3396E09)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-1811-11 in 1 CARTON12/10/2012
    180 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/01/2011
    Labeler - Andalou naturals (011472720)
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