1000 ROSES CC COLOR PLUS CORRECT SHEER NUDE SPF 30 (ZINC OXIDE) LOTION [ANDALOU NATURALS]

1000 ROSES CC COLOR PLUS CORRECT SHEER NUDE SPF 30 (ZINC OXIDE) LOTION [ANDALOU NATURALS]
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NDC 55560-0105-1
Set ID 344e0c05-f96d-4c4d-af85-d790f6c29e44
Category HUMAN OTC DRUG LABEL
Packager Andalou Naturals
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Zinc Oxide 20%

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  • Purpose

    Sunscreen

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  • Uses

    • Helps prevent sunburn.
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  • 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.

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

    • Daily, alone or under make-up.
    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
    • 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.
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  • Non Medicinal Ingredients

    Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil1, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil1, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Rosa Damascena (Rose) Flower Distillate1, Rosa Canina (Rosehip) Fruit Oil1, Punica Granatum (Pomegranate) Seed Oil1, Borago Officinalis (Borage) Seed Oil1, Iron Oxides, Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract12, Hibiscus Sabdariffa Flower Extract12, Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil1, Citrus Aurantium Dulcis (Orange) Peel Oil1


    1
    Certified Organic/Organic
    2
    Fair Trade/Biologique
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  • Other Information

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

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

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  • SPL UNCLASSIFIED SECTION

    Dist. by Andalou Naturals
    Novato, CA 94945 USA

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  • PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

    NEW LOOK

    ANDALOU
    NATURALS

    NON
    GMO

    CC

    1000 Roses®

    COLOR +
    CORRECT

    Sheer Nude
    SPF 30

    with Rose Stem Cells
    Soothing Resilience

    Broad Spectrum Protection

    FRUIT
    STEM
    CELL
    SCIENCE
    ®

    SENSITIVE

    NPN 80051204

    2 fl oz e 58 mL

    PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
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  • INGREDIENTS AND APPEARANCE
    1000 ROSES CC COLOR PLUS CORRECT SHEER NUDE SPF 30 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55560-0105
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 200 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Aloe vera leaf (UNII: ZY81Z83H0X)  
    Water (UNII: 059QF0KO0R)  
    Medium-chain triglycerides (UNII: C9H2L21V7U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Jojoba Oil (UNII: 724GKU717M)  
    Polyhydroxystearic acid (2300 mw) (UNII: YXH47AOU0F)  
    Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    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)  
    Hyaluronate sodium (UNII: YSE9PPT4TH)  
    Magnolia officinalis bark (UNII: 5M609NV974)  
    Indian frankincense (UNII: 4PW41QCO2M)  
    Rosa x damascena flower (UNII: JWB78P295A)  
    Rosa moschata oil (UNII: J99W255AWF)  
    Pomegranate Seed Oil (UNII: 0UI45XV0T6)  
    Borage seed oil (UNII: F8XAG1755S)  
    Ferric oxide yellow (UNII: EX438O2MRT)  
    Starch, corn (UNII: O8232NY3SJ)  
    White tea (UNII: O0M3396E09)  
    Hibiscus sabdariffa flower (UNII: 45TGG6IU6M)  
    Tocopherol (UNII: R0ZB2556P8)  
    Phenylethyl alcohol (UNII: ML9LGA7468)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Geraniol (UNII: L837108USY)  
    Vanillin (UNII: CHI530446X)  
    Geranium oil, algerian type (UNII: 5Q1I94P4WG)  
    Orange oil (UNII: AKN3KSD11B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55560-0105-1 1 in 1 CARTON 03/01/2014
    1 58 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 03/01/2014
    Labeler - Andalou Naturals (011472720)
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