Label: SOLAIRE PEAU PARFAITE MINERAL SCREEN SPF 30- zinc oxide cream

  • NDC Code(s): 63505-771-00
  • Packager: Yves Rocher North America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 19 %

    Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warnings

    For external use only

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    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Discontinue use and ask a doctor if rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • undefined

    • Apply generously and evenly 15 minutes before sun exposure. • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 am - 2 pm • wear long-sleeved shirts, pants, hats, and sunglasses. • For use on children less than 6 months of age, consult a doctor

  • Other Information

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

    • Store at 15-30°C (59-86°F).

  • Inactive Ingredients

    Water, Coco-Caprylate, Caprylic/ Capric Triglyceride, Cetearyl Isononanoate, Ethylhexyl Palmitate, Glycerin, Isopropyl Palmitate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Isopropyl Myristate, Magnesium Sulfate, Tocopherol, Polyglyceryl-3 Polyricinoleate, Decylene Glycol, Camellia Sinensis Leaf Extract, Lecithin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunfl ower) Seed Oil, 1,2-Hexanediol, Xanthan Gum, Hydrogenated Castor Oil, Euphorbia Cerifera (Candelilla) Wax/Euphorbia Cerifera Cera/Cire de candelilla, Sodium Chloride, Isostearic Acid, Silica, Polyhydroxystearic Acid, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Citric Acid.

  • Questions?

    CAN: 1-800-361-2746 / USA 1-800-321-3434.

  • Package Labeling:

    Label01

  • INGREDIENTS AND APPEARANCE
    SOLAIRE PEAU PARFAITE MINERAL SCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION190 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63505-771-001 in 1 CARTON09/01/2022
    1148 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2022
    Labeler - Yves Rocher North America Inc. (201826448)