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  5. Label Information: Fusion Mineral Body

FDA Label for Fusion Mineral Body

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 100 ML TUBE LABEL

Fusion Mineral Body Product Label

The following document was submitted to the FDA by the labeler of this product Isdin Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient



Zinc Oxide 12%


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

Otc - Do Not Use



  • Do not use on damaged or broken skin

Otc - When Using



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

Otc - Stop Use



  • Stop use and ask doctor if rash occurs

Otc - Keep Out Of Reach Of Children



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

Directions



  • Shake well before use
  • apply liberally 15 minutes before sun exposure
  • Reapply:
    • use a water-resistant sunscreen if swimming or sweating
    • at least every 2 hours.
    • Children under 6 months of age: 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 broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit your time in the sun, especially from 10 a.m.- 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information



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

Inactive Ingredients



Allantoin, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteth-20, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hexylene Glycol, Isoamyl Laurate, Jojoba Esters, Lecithin, Lysolecithin, Methylpropanediol, PEG-75 Stearate, Phenoxyethanol, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Pullulan, Pyrus Malus (Apple) Fruit Extract, Sclerotium Gum, Silica, Sodium Hydroxide, Squalane, Steareth-20, Tetrasodium Glutamate Diacetate, Tocopherol, Water, Xanthan Gum


Questions Or Comments?



Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin.com


Principal Display Panel - 100 Ml Tube Label



ISDIN
PHOTO

Fusion Mineral
BODY

BROAD SPECTRUM SPF 40

Ultralight protection and
hydration for all skin types

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label - fusion 01

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label - fusion 01


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