FDA.reportPublic FDA data

Stout Daily SPF for Men

Manufacturer
Stout Face Care Inc. | Apollo Health and Beauty Care
Effective date
2017-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:01

Label at a glance#

ProductStout Daily SPF for Men
Active ingredientZINC OXIDE
Label structure9 sections

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.8%

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

  • Helps prevent sunscreen

WARNINGS SECTION

​For external use only

OTC - DO NOT USE SECTION

​Do not use​ on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

​Stop use and ask a doctor if ​rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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 SECTION

  • protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

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 SECTION

STOÜT FACE CARE INC.

Suite 19130-2302 West 4th Ave.

Vancouver, BC V6K 4R8

1-888-315-1181

www.stoutfacecare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sto​üt

Daily SPF for Men

SUNSCREEN

Broad spectrum SPF 15

3.04 fl oz (90mL)

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71100-001-90Stout Daily SPF for Men90 mL in 1 TUBELIQUID902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71100-001STOUT DAILY SPF FOR MEN (SUNSCREEN) LIQUID [STOUT FACE CARE INC.]2Current NDC, Legacy NDC, 1 package rows20170301_cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71100-00171100-001-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISOSTEARIC ACIDX33R8U0062IACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERINPDC6A3C0OXIACT
GRAPE SEED OIL930MLC8XGGIACT
JOJOBA OIL724GKU717MIACT
SESAME OILQX10HYY4QVIACT
ALMOND OIL66YXD4DKO9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BORAGE SEED OILF8XAG1755SIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
SHEA BUTTERK49155WL9YIACT
MENTHOLL7T10EIP3AIACT
XANTHAN GUMTTV12P4NEEIACT
CITRUS SINENSIS SEED OIL9WMM6OQ58AIACT
PATCHOULI OILF3IN55X5POIACT
EVERNIA PRUNASTRIO3034Q5AHKIACT
BERGAMOT OIL39W1PKE3JIIACT
CEDRUS DEODARA WOOD OIL01O086PVD0IACT
TOCOPHEROLR0ZB2556P8IACT
CANDELILLA WAXWL0328HX19IACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stout Daily SPF for MenSUNSCREENStout Face Care Inc.cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd2017-03-01WarningsExact identifier
ndc (package): 71100-001-90
ndc (product): 71100-001
ndc11 (package): 71100000190
spl id: b4e2c44e-3027-45d1-969c-bd3e6596fcd5
spl set id: cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.