Label: 5-IN-1 TINTED FACE SUNSCREEN - FAIR- zinc oxide cream
5-IN-1 TINTED FACE SUNSCREEN - LIGHT- zinc oxide cream
5-IN-1 TINTED FACE SUNSCREEN - GOLDEN LIGHT- zinc oxide cream
5-IN-1 TINTED FACE SUNSCREEN - MEDIUM- zinc oxide cream

  • NDC Code(s): 69949-051-01, 69949-052-01, 69949-053-01, 69949-054-01
  • Packager: Synchronicity Spa, Inc. DBA Suntegrity
  • 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 July 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    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

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

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

    Aloe Barbadensis (Aloe Vera) Leaf Juice1, Capric/Caprylic Triglycerides2, Water (Aqua), Sorbitan Stearate2, Glyceryl Stearate2, Polyglyceryl-4 Isostearate2, Hexyl Laurate, Simmondsia Chinensis (Jojoba) Seed Oil1, Cetyl Dimethicone, Magnesium Sulfate 2, Helianthus Annuus (Sunflower) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Astaxanthin2, Hyaluronic Acid2, Chlorella Emersonii (Red Algae) Extract2, Camellia Sinensis (Green Tea) Extract1, Punica Granatum (Pomegranate) Seed Oil1, Polyaminopropyl Biguanide, Ethylhexylglycerin, Iron Oxides (C.I. 77492, C.I. 77491, C.I. 77499).

    1
    Certified Organic
    2
    Natural or Naturally-derived ingredients
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Fair

    sun
    tegrity®

    5-IN-1 TINTED
    SUNSCREEN MOISTURIZER

    MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

    BROAD SPECTRUM SPF 30

    SPF
    30

    NON-NANO ZINC OXIDE

    SHEER COVERAGE BB CREAM
    DEWY FINISH

    Antioxidants + Organic Oils
    Reef-Friendly
    Vegan

    NET WT 2 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Fair
  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Light

    sun
    tegrity®

    5-IN-1 TINTED
    SUNSCREEN MOISTURIZER

    MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

    BROAD SPECTRUM SPF 30

    SPF
    30

    NON-NANO ZINC OXIDE

    SHEER COVERAGE BB CREAM
    DEWY FINISH

    Antioxidants + Organic Oils
    Reef-Friendly
    Vegan

    NET WT 2 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Light
  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Golden Light

    sun
    tegrity®

    5-IN-1 TINTED
    SUNSCREEN MOISTURIZER

    MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

    BROAD SPECTRUM SPF 30

    SPF
    30

    NON-NANO ZINC OXIDE

    SHEER COVERAGE BB CREAM
    DEWY FINISH

    Antioxidants + Organic Oils
    Reef-Friendly
    Vegan

    NET WT 2 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Golden Light
  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Medium

    sun
    tegrity®

    5-IN-1 TINTED
    SUNSCREEN MOISTURIZER

    MOISTURIZE | HYDRATE | PROTECT | PRIME | COVER

    BROAD SPECTRUM SPF 30

    SPF
    30

    NON-NANO ZINC OXIDE

    SHEER COVERAGE BB CREAM
    DEWY FINISH

    Antioxidants + Organic Oils
    Reef-Friendly
    Vegan

    NET WT 2 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Medium
  • INGREDIENTS AND APPEARANCE
    5-IN-1 TINTED FACE SUNSCREEN - FAIR 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHLORELLA EMERSONII (UNII: 6701V9L3PV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69949-051-0156.7 g in 1 TUBE; Type 0: Not a Combination Product07/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2013
    5-IN-1 TINTED FACE SUNSCREEN - LIGHT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHLORELLA EMERSONII (UNII: 6701V9L3PV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69949-052-0156.7 g in 1 TUBE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2013
    5-IN-1 TINTED FACE SUNSCREEN - GOLDEN LIGHT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHLORELLA EMERSONII (UNII: 6701V9L3PV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69949-053-0156.7 g in 1 TUBE; Type 0: Not a Combination Product10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/01/2015
    5-IN-1 TINTED FACE SUNSCREEN - MEDIUM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHLORELLA EMERSONII (UNII: 6701V9L3PV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69949-054-0156.7 g in 1 TUBE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2013
    Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)
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