Label: SELF REFLECT PROBIOTIC SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 32- zinc oxide cream

  • 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 December 12, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 22.4%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and  early skin aging caused by the sun.
  • WARNINGS AND PRECAUTIONS

    Warning: For external use only.

  • DO NOT USE

    Do not use: on damaged or broken skin.

  • WHEN USING

    When using this products:

    • Keep out of eyes.
    • Rinse with water to remove.
  • STOP USE

    Stop use and ask a doctor: If rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    • If product is swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply generously 15 minutes before sun exposer.
    • Use a water resistant sunscreen if swimming or sweating. 
    • Reapply at least every 2 hours.
    • Sun protection measures: Spending time in the sun increase 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 sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.

    Other Information: Protect the product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Red Rasberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contains +/- Iron Oxides (Cl77491, Cl77492)

  • QUESTIONS

    Questions or Comments?

    Call toll free (877) 456-2582

  • PRINCIPAL DISPLAY PANEL

    Kinship Inc.,

    Corte Modera, CA 94925

    Made in USA

    lovekinship.com

    Self Reflect SPF 32.jpg

  • INGREDIENTS AND APPEARANCE
    SELF REFLECT PROBIOTIC SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 32 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE224 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    APPLE (UNII: B423VGH5S9)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    SHEANUT (UNII: 84H6HBP32L)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    VANILLA (UNII: Q74T35078H)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4181-21 in 1 CARTON12/12/2019
    1NDC:62742-4181-150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/12/2019
    Labeler - Allure Labs Inc (926831603)
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