FDA Label for Broad Spectrum Spf50 Spf 50
View Indications, Usage & Precautions
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
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.
- Limit time in the sun, especially from 10.00AM - 2.00PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
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:
Inactive Ingredients
Inactive Ingredients:
Water, Butyloctyl Salicylate,
Propylene Glycol, Acrylates
Copolymer, Euphorbia Cerifera
(Candelilla) Wax, Phenoxyethanol,
Hydroxyacetophenone,
Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Glycerin, Tocopheryl
Acetate, Polyacrylate
Crosspolymer-6, Ethylhexylglycerin,
Sodium Hyaluronate, Sodium
Hydroxide, Terminalia Ferdinandiana
(Kakadu Plum) Fruit Extract,
Disodium EDTA, Citric Acid
Other Information
Other Information:
Protect the product in this container
from excessive heat and direct sun.
User Safety Warnings
Directions: Apply generously 15 minutes before
sun exposure. Use a water-resistant sunscreen if
swimming or sweating. Reapply immediately after
towel drying. Reapply 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 - 2PM
Wear long-sleeved shirts, pants, hats, and
sunglasses Children under 6 months of age: Ask a
doctor.
Warnings And Precautions
Directions:
Apply generously 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 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 a
Broad Spectrum SPF value of 15 or
higher and other sun protection
measures including: Limit time in
the sun, especially from 10AM - 2PM
Wear long-sleeved shirts, pants,
hats, and sunglasses
* Please review the disclaimer below.
