Coola Classic Body Sunscreen Guava Mango Broad Spectrum Lotion
FDA Label NDC 79753-075

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coola Llc for the product Coola Classic Body Sunscreen Guava Mango Broad Spectrum (NDC 79753-075). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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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