FHF ELEVATED SHADE 100% MINERAL SUNSCREEN- sunscreen lotion

FHF Elevated Shade 100% Mineral Sunscreen by

Drug Labeling and Warnings

FHF Elevated Shade 100% Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide

Purpose

Sunscreen

Uses

Helps prevent sunburn
Provides moderate protection against sunburn

Warnings

Do not use on broken or damaged skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask docctor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact Poison Control.

Do not use

on broken or damaged skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

if rash occurs

Keep out of reach of children

If swallowed get medical help or contact Poison Control

Directions

Apply generously and evenly 15 minutes before sun exposure
Children under 6 months of age: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decreasse 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 especialy from 10a.m. - 2 p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

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

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Ethyl Macadamiate, Glycerin, Propanediol, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Polyglyceryl-10 Stearate, Cetearyl Olivate, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Hyaluronate, Sodium PCA, Niacinamide, Allantoin, Quercitin, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Sodium Chloride, Glyceryl Isostearate, Polyhydroxystearic, Sorbitan Olivate, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Iron Oxides, Triethoxysilylpropyl Acetyl Hydroxyprolinate, Phenoxyethanol, Caprylyl Glycol, Polymethyl Methacrylate, Tromethamine, Pisum Sativum (Dwarf Grey Sugar Pea) Extract, Parfum

Package Label

INGREDIENTS AND APPEARANCE

FHF ELEVATED SHADE 100% MINERAL SUNSCREEN 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.21 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-601-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/21/2022

Labeler - Owen Biosciences Inc (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences Inc		790003045	manufacture(59958-601)