Label: DECREE DAILY SHIELD 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 April 4, 2022

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  • 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.

    When using this product keep away from face to avoid breathing it.

    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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Danger

    Flammable. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • DIRECTIONS

    For sunscreen use:

    spray liberally and spread evenly by hand 15 minutes before sun exposure.

    -
    hold container 4 to 6 inches from the skin to apply.
    -
    do not spray directly into face. Spray on hands then apply to face.
    -
    do not apply in windy conditions.
    -
    use in a well-ventilated area.

    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.
    -
    reapply at least every 2 hours.
    -
    use a water resistant sunscreen if swimming or sweating.
  • INACTIVE INGREDIENTS

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

  • OTHER INFORMATION

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

  • PRINCIPAL DISPLAY PANEL - 75 ML Can Label

    Day Shield
    DAILY / AM + PM
    UV SHIELD
    SPRAY SOLAIRE
    BROAD SPECTRUM SPF 30
    SUNSCREEN

    D
    E
    C
    R
    E
    E

    BY DR AJ STURNHAM

    75ML e 2.53 FL OZ

    PRINCIPAL DISPLAY PANEL - 75 ML Can Label
  • INGREDIENTS AND APPEARANCE
    DECREE DAILY SHIELD BROAD SPECTRUM SPF 30 SUNSCREEN 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-3919
    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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SQUALANE (UNII: GW89575KF9)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-3919-175 mL in 1 CAN; 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)
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