MINERAL SUNSCREEN STICK SPF 50 FRAGRANCE-FREE- zinc oxide stick

Mineral Sunscreen Stick SPF 50 by

Drug Labeling and Warnings

Mineral Sunscreen Stick SPF 50 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Zinc Oxide 13.63%

Purpose

Suncreen

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

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 doctor if skin rash occurs

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 other 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
Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride
(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,
Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,
Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),
1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic
Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),
Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)

OTHER SAFETY INFORMATION

Other information

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

QUESTIONS

Questions or comments?
Call 760-940-2125

COOLA Label

SPF

50

70%+

Organic

COOLA​®

Classic

Sunscreen Stick

Fragrance-Free

Broad Spectrum SPF 50

Water-Resistant (80 Minutes)

+Plant Protection®

Net Wt. 0.6 OZ / 17.0 g

©2022 COOLA. Manufactured in the USA for COOLA, located in

Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  Questions or

Comments?  Call 760-940-2125. www.coola.com

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INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN STICK SPF 50  FRAGRANCE-FREE
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13.63 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CERESIN (UNII: Q1LS2UJO3A)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
SHEA BUTTER (UNII: K49155WL9Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-032-01	1 in 1 CARTON	01/16/2023
1		17 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/16/2023

Labeler - COOLA LLC (956990290)