SCALPHAIR MISTSUNSCREEN SPF30- coola scalphair mist organic sunscreen spf30 spray

ScalpHair MistSunscreen SPF30 by

Drug Labeling and Warnings

ScalpHair MistSunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by COOLA LLC, Naturich Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.50%

Homosalate 6.00%

Octisalate 5.00%

Octocrylene 7.00%

Purpose

Sunscreen

Uses

■ helps prevent sunburn

■ if used as directed with other sun protection measures

■ decreases the risk of skin cancer and early skin aging caused by the sun

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 contact a doctor if rash occurs

■ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ apply liberally and evenly 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 value 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-sleeved shirts, pants, hats, and sunglasses

■ children under 6 months of age: ask a doctor

Storage and Handling

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

Inactive Ingredients

Alcohol Denat (Organic)., Algae Extract, C12-15 Alkyl Benzoate, Centella Asiatica Extract, Cinnamidopropyltrimonium Chloride, Citrus Aurantium Bergamia (Bergamot) Fruit Oil (Organic), Elaeis Guineensis (Palm) Fruit Extract, Flavor, Glycerin (Organic), Glycine Soja (Soybean) Seed Extract, Oryza Sativa (Rice) Extract, Panthenol, Plumeria Acutifolia Flower Extract, Water (Aqua), Xylitol

Questions or Comments

Call 760-940-2125

Keep out of reach of children.

Dosage & Administration

Apply liberally to areas exposed to sun.

Package Label

INGREDIENTS AND APPEARANCE

SCALPHAIR MISTSUNSCREEN SPF30 
coola scalphair mist organic sunscreen spf30 spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.6 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 60 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.2 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	44.9 g  in 60 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-039-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2019

Labeler - COOLA LLC (956990290)

Registrant - Naturich Labs, Inc (124281663)

Establishment
Name	Address	ID/FEI	Business Operations
Naturich Labs, Inc		124281663	manufacture(79753-039)