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  5. Label Information: Sun Shades Mineral Plus Sunscreen

FDA Label for Sun Shades Mineral Plus Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENT

Sun Shades Mineral Plus Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. 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.

Otc - Active Ingredient



Active ingredient
Octisalate 5%, Zinc oxide 10%


Otc - Purpose



Purpose
Sunscreen


Indications & Usage



Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity in the water or sweating

Warnings



Warnings
For external use only


Otc - When Using



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


Otc - Stop Use



Stop use and ask a doctor if rash or irritation develops and lasts


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions

  • apply liberally and evenly to all exposed areas before sun exposure
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

Inactive Ingredient



Inactive ingredients
aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum


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