Label: 1000 ROSES DAILY SHADE FACIAL SPF 18- octisalate, octocrylene, and avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 15, 2019

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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, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive 8 Berry Complex1, Dimethicone, Lecithin, Tocopherol, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Panthenol, Allantoin, Rosa Damascena (Rose) Flower Distillate1, Magnesium Ascorbyl Phosphate (Vitamin C), Chamomilla Recutita (Chamomile) Flower Extract1, Calendula Officinalis Flower Extract1, Rosa Canina (Rosehip) Fruit Oil1, Punica Granatum (Pomegranate) Seed Oil1, Camellia Sinensis (White Tea) Leaf Extract12, Aspalathus Linearis (Rooibos) Extract12, Hibiscus Sabdariffa Flower Extract12, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil1, 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

    1000 Roses®
    DAILY SHADE

    Facial Lotion
    SPF 18

    with Rose Stem Cells
    Soothing Resilience

    Broad Spectrum Protection

    FRUIT
    STEM
    CELL

    SCIENCE®

    SENSITIVE

    2.7 fl oz e 80 mL

    Principal Display Panel - 80 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    1000 ROSES DAILY SHADE FACIAL SPF 18 
    octisalate, octocrylene, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-0103
    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)  
    ROSA RUGOSA FLOWER (UNII: 969IQC5YJU)  
    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)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    WHITE TEA (UNII: O0M3396E09)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GERANIOL (UNII: L837108USY)  
    VANILLIN (UNII: CHI530446X)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-0103-11 in 1 CARTON03/01/2014
    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 FINALpart35203/01/2014
    Labeler - Andalou naturals (011472720)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc189788201MANUFACTURE(55560-0103)
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