Label: STOUT DAILY SPF FOR MEN- sunscreen liquid
- NDC Code(s): 71100-001-90
- Packager: Stout Face Care Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 1, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
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
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
STOUT DAILY SPF FOR MEN
sunscreen liquidProduct 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)
