Label: RAIN SKINCARE MINERAL FACIAL SUNSCREEN- zinc oxide cream

  • NDC Code(s): 83836-013-50
  • Packager: Rain Africa Innovations (Pty) Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

  • Uses:

    Helps prevent sunburn.

    Helps prevent sunburn

  • Directions:

    Apply a generous amount at least 15 minutes before sun exposure; reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.

    Apply a generous amount at least 15 minutes before sun exposure; reapply at least every 2 hours.

  • Sun Protection Measures:

    Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 a.m.-2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses

  • Warnings:

    Keep out of reach of children

    For children under 6 months of age: consult a doctor.

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

    Do not use on damaged or broken skin.

    Keep out of eyes. Rinse with water to remove.

    Stop use and consult a doctor if rash occurs.

    Keep out of reach of children

    Stop use and consult a doctor if rash occurs.

    For children under 6 months of age: consult a doctor.

    Stop use and consult a doctor if rash occurs.

  • STORAGE AND HANDLING

    Store below 25℃ away from direct sunlight.

  • INACTIVE INGREDIENT

    Ingredients

    Aqua (Water), Zinc Oxide, Caprylic/Capric Triglyceride, Glycerin, Aloe Ferox Leaf Extract, Polyhydroxystearic Acid, Polysorbate 20, Silica, Glyceryl Stearate Citrate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Benzyl Alcohol, Daucus Carota Sativa (Carrot) Seed Oil, Glyceryl Caprylate, Bentonite, C13-15 Alkane, Coco-Caprylate/Caprate, Squalane, Glyceryl Stearate, Cetyl Alcohol, Levulinic Acid, Sodium Levulinate, Cellulose Gum, Tocopherol, Xanthan Gum, Hydrolyzed Jojoba Esters, Dehydroacetic Acid, Sodium Hyaluronate, Citric Acid, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool

  • Ingredients

    Aqua (Water), Zinc Oxide, Caprylic/Capric Triglyceride, Glycerin, Aloe Ferox Leaf Extract, Polyhydroxystearic Acid, Polysorbate 20, Silica, Glyceryl Stearate Citrate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Benzyl Alcohol, Daucus Carota Sativa (Carrot) Seed Oil, Glyceryl Caprylate, Bentonite, C13-15 Alkane, Coco-Caprylate/Caprate, Squalane, Glyceryl Stearate, Cetyl Alcohol, Levulinic Acid, Sodium Levulinate, Cellulose Gum, Tocopherol, Xanthan Gum, Hydrolyzed Jojoba Esters, Dehydroacetic Acid, Sodium Hyaluronate, Citric Acid, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool.

  • Mineral Facial Sunscreen

    Mineral Facial Sunscreen

    SPF 40

    High Protection

    Broad Spectrum UVB/UVA

  • INGREDIENTS AND APPEARANCE
    RAIN SKINCARE MINERAL FACIAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83836-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.231 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) 0.012 g  in 1 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.009 g  in 1 g
    CARROT SEED OIL (UNII: 595AO13F11) 0.008 g  in 1 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.0105 g  in 1 g
    WATER (UNII: 059QF0KO0R) 0.48575 g  in 1 g
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.0075 g  in 1 g
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) 0.005 g  in 1 g
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 0.005 g  in 1 g
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) 0.0016 g  in 1 g
    DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.001 g  in 1 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.099 g  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.0267 g  in 1 g
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00006 g  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.0036 g  in 1 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.002 g  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.0123 g  in 1 g
    ALOE FEROX LEAF (UNII: 0D145J8EME) 0.02 g  in 1 g
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.0165 g  in 1 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.016 g  in 1 g
    SORBITAN OLIVATE (UNII: MDL271E3GR) 0.01 g  in 1 g
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.002 g  in 1 g
    C13-15 ALKANE (UNII: 114P5I43UJ) 0.005 g  in 1 g
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.0001 g  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE) 0.002 g  in 1 g
    LEVULINIC ACID (UNII: RYX5QG61EI) 0.0035 g  in 1 g
    CETEARYL OLIVATE (UNII: 58B69Q84JO) 0.01 g  in 1 g
    BENTONITE (UNII: A3N5ZCN45C) 0.005 g  in 1 g
    SQUALANE (UNII: GW89575KF9) 0.005 g  in 1 g
    SODIUM LEVULINATE (UNII: VK44E1MQU8) 0.0035 g  in 1 g
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00006 g  in 1 g
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00006 g  in 1 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83836-013-501 in 1 BOX04/01/2024
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2024
    Labeler - Rain Africa Innovations (Pty) Ltd (539150153)
    Registrant - Rain Africa Innovations (Pty) Ltd (539150153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rain Africa Innovations (Pty) Ltd539150153manufacture(83836-013)