STOUT DAILY SPF FOR MEN- sunscreen liquid

Stout Daily SPF for Men by

Drug Labeling and Warnings

Stout Daily SPF for Men by is a Otc medication manufactured, distributed, or labeled by Stout Face Care Inc., Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 9.8%

PURPOSE

Zinc Oxide 9.8%............................Sunscreen

INDICATIONS & USAGE

• Helps prevent sunscreen

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 a doctor if ​rash or irritation develops and lasts.

​Keep out of reach of children​.  If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• apply liberally and evenly 15 minutes before sun exposure
• apply to all skin exposed to sun
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• ​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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months of age: Ask a doctor

STORAGE AND HANDLING

• protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Purified water (eau), Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Glycerin, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Caprylyl Glycol, Borago Officinalis Seed Oil, Cannabis Sativa Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Hippophae Rhamnoides Seed Oil, Butyrospermum Parkii (Shea) Butter, Menthol, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Pogostemon Cablin Oil, Evernia Prunastri (Oakmoss) Extract, Citus Aurantium Bergamie (Bergamot Fruit) Oil, Cedrus Deodara Wood Oil, Tocopherol, Euphorbia Cerifera (Candelilla) Wax, Aloe Barbadensis Leaf Powder

DESCRIPTION

STOÜT FACE CARE INC.

Suite 19130-2302 West 4th Ave.

Vancouver, BC V6K 4R8

1-888-315-1181

www.stoutfacecare.com

PRINCIPAL DISPLAY PANEL

Sto​üt

Daily SPF for Men

SUNSCREEN

Broad spectrum SPF 15

3.04 fl oz (90mL)

INGREDIENTS AND APPEARANCE

STOUT DAILY SPF FOR MEN 
sunscreen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71100-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.82 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
GRAPE SEED OIL (UNII: 930MLC8XGG)
JOJOBA OIL (UNII: 724GKU717M)
SESAME OIL (UNII: QX10HYY4QV)
ALMOND OIL (UNII: 66YXD4DKO9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BORAGE SEED OIL (UNII: F8XAG1755S)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
SHEA BUTTER (UNII: K49155WL9Y)
MENTHOL (UNII: L7T10EIP3A)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRUS SINENSIS SEED OIL (UNII: 9WMM6OQ58A)
PATCHOULI OIL (UNII: F3IN55X5PO)
EVERNIA PRUNASTRI (UNII: O3034Q5AHK)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CEDRUS DEODARA WOOD OIL (UNII: 01O086PVD0)
TOCOPHEROL (UNII: R0ZB2556P8)
CANDELILLA WAX (UNII: WL0328HX19)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71100-001-90	90 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2017

Labeler - Stout Face Care Inc. (203411616)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(71100-001)