FHF Elevated Shade 100% Mineral Sunscreen

Manufacturer: Owen Biosciences Inc
Effective date: 2024-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:31:26

Label at a glance#

ProductFHF Elevated Shade 100% Mineral Sunscreen

Active ingredientZINC OXIDE

Label structure8 sections

Indications and uses

Helps prevent sunburn Provides moderate protection against sunburn

Dosage and administration

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-s...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn
Provides moderate protection against sunburn

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

on broken or damaged skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact Poison Control

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59958-601-01	FHF Elevated Shade 100% Mineral Sunscreen	50 g in 1 BOTTLE	LOTION	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59958-601	FHF ELEVATED SHADE 100% MINERAL SUNSCREEN (SUNSCREEN) LOTION [OWEN BIOSCIENCES INC]	2	Current NDC, Legacy NDC, 1 package rows	20241030_dabd3b95-01d3-014c-e053-2a95a90a0fec.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

FHF Elevated Shade 100% Mineral Sunscreen
sunscreen
ZINC OXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59958-601	59958-601-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Owen Biosciences Inc	dabd3b95-01d3-014c-e053-2a95a90a0fec	2024-10-28	Warnings	Exact identifier ndc (package): 59958-601-01 ndc (product): 59958-601 ndc11 (package): 59958060101 spl id: 258f9ba3-0149-a6bd-e063-6394a90add55 spl set id: dabd3b95-01d3-014c-e053-2a95a90a0fec

Reported adverse events (FAERS/openFDA)#

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