Label: PROFESSIONAL SOLUTIONS - YOUTH BOOST DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide and zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 30, 2020

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Titanium Dioxide 7.2%, Zinc Oxide 4.0%.

  • Purpose

    Sunscreen

  • USES

    Helps prevent sunburn.

  • 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 occurs.

  • DIRECTIONS

    Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
  • INACTIVE INGREDIENTS

    Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-10 Oleate, Coco-Caprylate/Caprate, Styrene/Acrylates Copolymer, Polyhydroxystearic Acid, Rosa Damascena Flower Water, Phenoxyethanol, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Alumina, Butylene Glycol, Polyglyceryl-2 Caprate, Microcrystalline Cellulose, Potassium Cetyl Phosphate, Polyglyceryl-3 Polyricinoleate, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Marrubium Vulgare Meristem Cell Culture, Polyglyceryl-3 Diisostearate, Triethoxycaprylylsilane, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Cellulose Gum, Glyceryl Caprylate, Squalane, Carbomer, Polysorbate 20, Aspalathus Linearis Extract, Palmitoyl Tripeptide-1, Xanthan Gum, Palmitoyl Tetrapeptide-7, Polygonum Aviculare Extract.

  • OTHER INFORMATION

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

  • SPL UNCLASSIFIED SECTION

    Manufactured By: Professional Solutions, Boca Raton, FL 33487

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    Professional
    Solutions®
    PURE SCIENCE. BETTER SKIN

    youth boost
    daily moisturizer
    broad spectrum
    spf 30 sunscreen

    protects + moisturizes

    2 Fl. Oz. (60mL)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROFESSIONAL SOLUTIONS - YOUTH BOOST DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-2700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.2 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Propanediol (UNII: 5965N8W85T)  
    Polyglyceryl-10 Oleate (UNII: 55C81W76DH)  
    Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)  
    Rosa X Damascena Flower Oil (UNII: 18920M3T13)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Aluminum Stearate (UNII: U6XF9NP8HM)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Polyglyceryl-2 Caprate (UNII: JX7WXJ41DH)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Polyglyceryl-3 Pentaricinoleate (UNII: 7Q0OK5DOT4)  
    Jojoba Oil (UNII: 724GKU717M)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Sucrose Stearate (UNII: 274KW0O50M)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Glyceryl Monocaprylate (UNII: TM2TZD4G4A)  
    Squalane (UNII: GW89575KF9)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
    Polygonum Aviculare Top (UNII: ZCD6009IUF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-2700-160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:66163-2700-230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/01/2020
    Labeler - Cosmetic Solutions LLC (807907928)