FDA Label for Coola Classic Body Sunscreen Guava Mango Broad Spectrum Spf 50

View Indications, Usage & Precautions

Coola Classic Body Sunscreen Guava Mango Broad Spectrum Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Coola Llc. 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.

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DRUG FACTS


Otc - Active Ingredient



Active Ingredients
Avobenzone 1.75%    Homosalate 5.0%
Octisalate 2.0%          Octocrylene 5.0%


Otc - Purpose



Purpose
Sunscreen


Indications & Usage



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



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.


Dosage & Administration



Directions
• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 of 15 or higher and after sun protection.
measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor


Inactive Ingredient



Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Brassica
Campestris (Rapeseed) Seed Oil, Butylene Glycol,
Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus
Tinctorius (Safflower) Oleosomes, Carthamus
Tinctorius (Safflower) Seed Oil (ORGANIC), Cetearyl
Alcohol, Cetyl Palmitate, Decyl Glucoside, Dimethicone,
Flavor*, Glycerin (ORGANIC), 1,2-Hexanediol,
Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia
Flexuosa (Buriti) Fruit Oil, Methyl Dihydroabietate,
Opuntia Ficus-Indica Flower Extract, Polyacrylate
Crosspolymer-6, Polysilicone-11, Rubus Idaeus
(Raspberry) Seed Oil, Silica, Sodium Hydroxide, Sodium
Phytate, Sorbitan Oleate, Sorbitan Palmitate, Tropolone,
Water, Xanthan Gum


Other Safety Information



Other Information

  • protect this product from excessive heat and direct sun
  • may stain fabrics

Otc - Questions



Questions or Comments? Call 760-940-2125


Package Label



                                      SPF
                                       50

                                      70% +
                                     Organic

                                     COOLA

                                     Classic
                                Body Sunscreen
                                  Guava Mango

                                Ultra Lightweight
                             Hydrates & Nourishes
                              +Plant Protection®

                          Broad Spectrum SPF 50
                      Water Resistant (80 Minutes)

                             3.4 FL OZ / 100 mL

2020 COOLA. Distributed by: COOLA LLC,

located in Sunny& Cool San Diego, CA 92009.

All Rights Reserved. ww.coola.com

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