SPORT NATURAL MINERAL BODY SUNSCREEN

SPORT NATURAL MINERAL BODY SUNSCREEN by

Drug Labeling and Warnings

SPORT NATURAL MINERAL BODY SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Synchronicity Spa, Inc. DBA Suntegrity. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPORT NATURAL MINERAL BODY SUNSCREEN- zinc oxide cream 
Synchronicity Spa, Inc. DBA Suntegrity

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.

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SPORT NATURAL MINERAL BODY SUNSCREEN

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
  • Reapply:
    • after 80 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 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 10am to 2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age; Ask a doctor

Inactive Ingredients

ricinus communis (castor) oil1, cera alba (beeswax)1, cocos nucifera (coconut) oil1, olea europaea (olive) fruit oil1, simmondsia chinensis (jojoba) oil1, butyrospermum parkii (shea) butter1, helianthus annuus (sunflower) seed oil1, tocopherol,

  • 1 certified organic ingredient

    • Other Information

    • protect the product in this container from excessive heat and direct sun

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label - Orange Scent

    sun
    tegrity®

    NATURAL MINERAL
    SUNSCREEN
    SPORT

    Water Resistant
    (80 Minutes)

    SPF 30
    BROAD SPECTRUM SPF 30
    UVA/UVB | Non-Nano Zinc Oxide

    NSF
    contains organic
    ingredientsCM

    For Babies, Kids, & Adults
    Reef Friendly & Cruelty Free
    Light Orange Scent

    NET WT 3 OZ (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label - Orange Scent

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label

    sun
    tegrity®

    NATURAL MINERAL
    SUNSCREEN
    SPORT

    Water Resistant
    (80 Minutes)

    SPF 30
    BROAD SPECTRUM SPF 30
    UVA/UVB | Non-Nano Zinc Oxide

    NSF
    contains organic
    ingredientsCM

    For Babies, Kids, & Adults
    Reef Friendly & Cruelty Free
    Unscented

    NET WT 3 OZ (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Label
    SPORT NATURAL MINERAL BODY SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69949-210
    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
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69949-210-0185 g in 1 TUBE; Type 0: Not a Combination Product03/01/201903/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/201903/31/2021
    SPORT NATURAL MINERAL BODY SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69949-211
    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
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69949-211-0185 g in 1 TUBE; Type 0: Not a Combination Product11/01/202110/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/202110/31/2023
    Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)

    Revised: 7/2023
    Document Id: 3129f637-c20f-4737-8832-9bf9d60c409b
    Set id: fdb2108d-fb8b-4ef0-9836-fd0e04135f3b
    Version: 3
    Effective Time: 20230725