SHEER MATTE SPF 30- zinc oxide 10.5% lotion

Sheer Matte SPF 30 by

Drug Labeling and Warnings

Sheer Matte SPF 30 by is a Otc medication manufactured, distributed, or labeled by COOLA, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredients
Zinc Oxide 10.5%

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

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes.
Rinse with water to remove.

STOP USE

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
shake well
apply liberally 15 minutes before sun exposure
reapply:
    after 80 minutes 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),
Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl
Salicylate, Polyglyceryl-4 Laurate/Succinate,
Glycerin (ORGANIC), Methyl Methacrylate
Crosspolymer, Poly C-10-30 Alkyl Acrylate, Sorbitan
Oleate, Trimethoxybenzylidene Pentanedione,
Arachidyl Alcohol, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Carthamus
Tinctorius (Safflower) Oleosomes, Mauritia Flexuosa
Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed
Oil (ORGANIC), Limnanthes Alba (Meadowfoam)
Seed Oil, Oenothera Biennis (Evening Primrose) Oil
(ORGANIC), Rosa Canina Seed Oil (ORGANIC),
Helianthus Annuus (Sunflower) Seed Oil, Ricinus
Communis (Castor) Seed Oil, Opuntia Vulgaris
Extract, Behenyl Alcohol, Polyhydroxystearic Acid,
Isostearic Acid, Benzyl Alcohol, Arachidyl Glucoside,
Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Citric
Acid, Hydrogenated Polyisobutene, Iron Oxides, Cl
77891, Sorbitan Isostearate, Cl 77492, Cl 77491,
Disteardimonium Hectorite, Cl 77499, Propylene
Carbonate, Gluconolactone, Sodium Benzoate

OTHER SAFETY INFORMATION

Other Information

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

QUESTIONS

Questions or Comments? Call 760-940-2125

Package for COOLA Mineral Face Sunscreen Sheer Matte SPF 30

SPF 30\COOLA

Mineral

Face Sunscreen

Sheer Matte

1.7 FL OZ / 30 mL

Distributed by:

COOLA LLC, Located at

6023 Innovation Way in in Sunny & Cool San Diego, CA 92009.

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

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INGREDIENTS AND APPEARANCE

SHEER MATTE SPF 30 
zinc oxide 10.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
RASPBERRY SEED OIL (UNII: 9S8867952A)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
FERROUS OXIDE (UNII: G7036X8B5H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-044-01	1 in 1 PACKAGE	02/01/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2022

Labeler - COOLA (956990290)

Registrant - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(79753-044)