FDA Label for Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 Spf 50

View Indications, Usage & Precautions

Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Naked Sundays Pty Ltd. 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.

Active Ingredients



Avobenzone 3%

Homosalate 10%

Octilsalate 5%


Purpose



Sunscreen


Uses



Use:
Helps prevent sunburn.
If used as directed with other sun
protection measures (see directions),
decreases the risk of skin cancer and
early skin ageing caused by the sun.


Warnings



Warnings: For external use only.
Skin Cancer/Skin Aging Alert: Spending
time in the sun increases your risk of skin
cancer and early skin aging. This product
has been shown only to help prevent
sunburn, not skin cancer or early skin
aging. Do not use on damaged or broken skin.
When using this product: Keep out of
eyes. Rinse with water to remove.
Stop use and ask a doctor: If rash occurs.
Keep out of reach of children: If product is
swallowed, get medical help or contact a
Poison Control Center right away.
Use a water-resistant sunscreen if
swimming or sweating


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



  • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
  • Reapply after 80 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Reapply at least every 2 hours.
  • Children under 3 years 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10.00AM - 2.00PM
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients



Inactive Ingredients:
Water, Butyloctyl Salicylate, Ethylhexyl
Methoxycrylene, Dimethicone, Potassium
Cetyl Phosphate, Glyceryl Stearate, Sodium
Polyacrylate, Niacinamide, Tocopheryl
Acetate, Hydroxyacetophenone, Sodium
Benzoate, Glyceryl Caprylate, Sodium
Hyaluronate, Disodium EDTA, Citric Acid,
Sodium Hydroxide


Other Information



Other Information:
Protect the product in this container
from excessive heat and direct sun.


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