SUN DEFENSE MINERALS (FAIR)- zinc oxide, titanium dioxide powder

Sun Defense Minerals (Fair) by

Drug Labeling and Warnings

Sun Defense Minerals (Fair) by is a Otc medication manufactured, distributed, or labeled by Eminence Organic Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions

Before use, shake or tap well
Apply liberally 15 minutes before sun exposure
Reapply

After 40 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours

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 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-sleeved shirts, pants, hats, and sunglasses.

WARNINGS

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 occurs

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

INACTIVE INGREDIENT

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

INDICATIONS & USAGE

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 18.5%; Zinc Oxide 23.5%......Sunscreen

PURPOSE

Purpose: Sunscreen

PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredients Purpose

Titanium Dioxide 18.5%; Zinc Oxide 23.5%......Sunscreen

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 occurs

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

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

Reapply

After 40 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 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-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

INGREDIENTS AND APPEARANCE

SUN DEFENSE MINERALS (FAIR) 
zinc oxide, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15751-3601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	235 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	185 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PHENYLPROPANOL (UNII: 0F897O3O4M)
PROPANEDIOL (UNII: 5965N8W85T)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
IRON OXIDES (UNII: 1K09F3G675)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
OCTYLDODECANOL (UNII: 461N1O614Y)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15751-3601-1	1 in 1 BOX	03/01/2025
1		5.5 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - Eminence Organic Skin Care (205753317)