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  5. Label Information: Sun Protection

FDA Label for Sun Protection

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSES
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. TATTOO CARE SUN PROTECTION SUNSCREEN AND SKIN PROTECTANT OINTMENT SPF 30+, 1.4 OZ (40G) 82806-200-01

Sun Protection Product Label

The following document was submitted to the FDA by the labeler of this product Makra Kozmetika D.o.o.. 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.

Drug Facts




Active Ingredients



Lanolin 24.91%

Avobenzone 2.5%

Octinoxate 7%


Purposes



Skin Protectant

Sunscreen

Sunscreen


Uses



  • temporarily protects minor:

    • • cuts

    • scrapes

    • burns

    • temporarily protects chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
    • 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 skin
  • on deep or punture wounds
  • on animal bites
  • on serious burns

When Using This Product



  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If



  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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

    • children under 6 months of age: ask a doctor

Inactive Ingredients



Water, petrolatum, chocolate (Theobroma cacao) butter, calendula (Calendula officinalis) flower extract, almond (Prunus dulcis) oil, cetearyl alcohol, jojoba (simmondsia chinesis) seed oil,sodium benzoate, potassium sorbate, bisbolol, allantoin, tocopheryl acetate, sodium cetearyl sulfate, coumarin, sodium lauryl sulfate, linalool, citric acid, fragrance, cinnamyl alchohol, benzyl salicylate, geraniol.


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