Label: PREVENTION PLUS DAILY TINTED MOISTURIZER SPF 30- 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 September 17, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 21.0%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures, 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.If contact occurs 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 swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions For Sunscreen Use:

    • Apply generously 15 minutes before sun exposure.
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating. 
    •    Immediatly after towel drying. 
    •    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 value of 15 or higher and other sun protection measures including:
    •  limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua/Water/EAU, Caprylyc/Capric Triglyceride, Cyclopentasiloxane, Glycerin, Butyloctyl Salicylate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Butyrospermum Parkii Nut Extract, Styrene/Acrylates Copolymer, Cl 77891, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Cyclohexasiloxane, Helianthus Annus (Sunflower) seed oil, Polysilicone-31, Sorbitan Stearate, Cl 77492, Cetyl Alcohol, Phenoxyethanol, HEA/Sodium Acryolydimethyltaurate/Steareth-20 Methacrylate Copolymer, Citrus Aurantium Dulcis (Orange) peel oil, Hydrolyzed jojoba esters, Limonene, Caprylyl Glycol, Allantoin, C13-14 Isoparaffin, Laminaria Digitata Extract, Artemisia Vulgaris Extract, Ethylhexylglycerin, Hexylene Glycol, Cl 77491, Citrus Nobilis (Mandarin Orange) Peel Oil, Xanthan gum, Bisabolol, Polysorbate 80, Tocopheryl Acetate, Triethoxycaprylylsilane, Cl 77499, Camellia Sinensis Leaf Extract, Decyl Glucoside, Erythritol, Sodium Hyaluronate, Biosaccharide Gum-1, Vanilla Planifolia Fruit Extract, Glucose, Hydrolyzed Pea Protein, Pyruvic Acid, Sodium Chloride, Barosma Betulina Leaf Oil, Tetrahexyldecyl ascorbate, Alumina, Magnesium Oxide, Potassium Sorbate, Sodium Benzoate, Homarine HCL, Sodium Succinate, Arabidopsis Thaliana Extract, Micrococcus Lysate, Plankton Extract, Ergothioneine.

  • PRINCIPAL DISPLAY PANEL

    Manufactured for IMAGE Skincare, Lantana, FL 33462 USA

    Manufactured in USA from globally sourced ingredients and components

    www.ImageSkincare.com

    Prevention Plus Daily Tinted Moisturizer SPF 30

    Call 800-796-7546

  • INGREDIENTS AND APPEARANCE
    PREVENTION PLUS DAILY TINTED MOISTURIZER SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE210 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    STEARETH-20 METHACRYLATE (UNII: A268NZ57NB)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MANDARIN OIL (UNII: NJO720F72R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    VANILLA (UNII: Q74T35078H)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    PEA PROTEIN (UNII: 7Q50F46595)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    ANACYSTIS NIDULANS (UNII: UV4FTL6UAW)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4170-1170 g in 1 TUBE; Type 0: Not a Combination Product09/20/2019
    2NDC:62742-4170-31 in 1 CARTON09/20/2019
    2NDC:62742-4170-291 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:62742-4170-47 g in 1 TUBE; Type 0: Not a Combination Product09/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/20/2019
    Labeler - Allure Labs Inc (926831603)