Label: ALL CALM CLINICAL REDNESS CORRECTOR SPF 50- titanium dioxide and zinc oxide liquid

  • NDC Code(s): 68078-023-02, 68078-023-24
  • Packager: Colorescience
  • 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 October 7, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 11.6%Sunscreen
    Zinc Oxide 8.6%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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months: 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

    Cyclopentasiloxane, Caprylic/Capric Triglyceride, Water/Aqua/Eau, Dimethicone Crosspolymer, Niacinamide, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Crithmum Maritimum Extract, Magnolia Officinalis Bark Extract, Zingiber Officinale (Ginger) Root Extract, Magnesium Carboxymethyl Beta-Glucan, Jojoba Esters, Bisabolol, Silica, Polyhydroxystearic Acid, Dimethiconol, Alumina, Glyceryl Behenate/Eicosadioate, Phenoxyethanol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Dehydroacetic Acid, Benzoic Acid, Glycolic Acid, Chloroacetic Acid, Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499).

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Questions or comments?

    Call toll free 866.426.5673

  • SPL UNCLASSIFIED SECTION

    Dist. in USA by
    colorescience®
    Carlsbad, CA 92011

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

    colorescience®

    ALL CALM™

    CLINICAL REDNESS
    CORRECTOR

    Instantly neutralizes redness
    Soothes sensitive skin

    50
    Broad Spectrum
    SPF 50 Sunscreen
    PA++++

    1 fl. oz. / 30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ALL CALM CLINICAL REDNESS CORRECTOR SPF 50 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide116 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION86 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    Niacinamide (UNII: 25X51I8RD4)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    Glyceryl Behenate/Eicosadioate (UNII: 73CJJ317SR)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Tocopherol (UNII: R0ZB2556P8)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    GINGER (UNII: C5529G5JPQ)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Chloroacetic Acid (UNII: 5GD84Y125G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-023-241 in 1 CARTON08/02/2017
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68078-023-021 mL in 1 PACKET; Type 0: Not a Combination Product08/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/02/2017
    Labeler - Colorescience (128731929)
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