Label: SOLARA SUNCARE - POUT PROTECTOR SPF-15- zinc oxide cream

  • NDC Code(s): 73054-104-01, 73054-104-11
  • Packager: SOLARA SUNCARE, INC.
  • Category: HUMAN OTC DRUG LABEL

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 March 29, 2023

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  • ACTIVE INGREDIENTS

    Non-Nano, Non-Coated Zinc Oxide 20%

  • PURPOSE

    Sunscreen

  • USES

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • shake or knead before each use
    • apply generously and evenly 15 minutes before sun exposure
    • reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENTS

    Aqua (Water), Bisabolol, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Ethylhexanoate, Cetearyl Nonanoate, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Fructose, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Helianthus, Annuus (Sunflower) Seed Wax, Isostearic Acid, Lecithin, Mentha Spicata (Spearmint) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Portulaca Pilosa Extract (Purslane), Rubus Laciniatus (Blackberry) extract, Sorbitan Isostearate, Sorbitol/ Sebacic Acid Copolymer Behenate, Stearic Acid, Sucrose Cocoate (Stevia), Tiare Flower Extract, Tocopherol, Tribehenin , Withania Somnifera (Ashwaganda) Root Extract

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun.
  • QUESTIONS OR COMMENTS

    • 1-855-859-1600 (9am – 5pm ET)
  • PRINCIPAL DISPLAY PANEL

    01b UC_Pout Protector

  • INGREDIENTS AND APPEARANCE
    SOLARA SUNCARE - POUT PROTECTOR   SPF-15
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PORTULACA PILOSA WHOLE (UNII: II29C6E5R3)  
    RUBUS LACINIATUS WHOLE (UNII: HYX7YK7LE7)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SORBITOL (UNII: 506T60A25R)  
    SEBACIC ACID (UNII: 97AN39ICTC)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73054-104-111 in 1 BOX07/06/2019
    1NDC:73054-104-0110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/06/2019
    Labeler - SOLARA SUNCARE, INC. (040998319)
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