SPF-40 FACIAL MOISTURIZER- zinc oxide and titanium dioxide lotion

SPF-40 facial moisturizer by

Drug Labeling and Warnings

SPF-40 facial moisturizer by is a Otc medication manufactured, distributed, or labeled by Mineral Fusion brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

PURPOSE

Provides broad-spectrum protection from the sun's damaging rays while moisturizers and peptides lend anti-aging benefits.

RECOMMENDED FOR

All skin types.

DIRECTIONS

Apply a liberal amount daily before sun exposure. Initial whiteness turns clear after application. Reapply every 2-3 hours to maintain protection.

USES

Helps prevent sunburn.

ACTIVE INGREDIENTS

7.5% Titanium Dioxide, 5.0% Zinc Oxide

INACTIVE INGREDIENTS

Water (Aqua), Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Glycerin, Hexyl Laurate, Pollyglyceryl-4 Isostearate, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea Butter), Panthenol, Magnesium Aspartate, Zinc Gluconate, Copper Gluconate (Copper Peptides), Pamitoyl Pentapeptide-4, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Tocopherol Acetate, Allantoin, Sodium PCA, Soy Lecithin, Magnesium Aluminum Silicate, Camellia Sinensis (Green Tea) Extract, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Ethylhexylglycerin, Phenoxyethanol

WARNING

For external use only.

Do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

Mild skin irritation may occur. Stop use and ask a physician if irritation is severe.

Do not use on infants under 6 months old.

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

SUNBURN ALERT

Limiting sun exposure, wearing protective clothing, and using a sunscreen agent may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

SPL UNCLASSIFIED SECTION

Distributed By:
glōProfessional
Denver, CO 80223

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

SUNSCREEN

glōtherapeutics

SPF 40 Facial
Moisturizer

7.5% Titanium Dioxide,
5% Zinc Oxide,
Peptides

FACIAL SUNSCREEN

INGREDIENTS AND APPEARANCE

SPF-40 FACIAL MOISTURIZER 
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55789-0101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	5 g  in 100 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
glyceryl monostearate (UNII: 230OU9XXE4)
cetyl dimethicone 25 (UNII: U4AS1BW4ZB)
glycerin (UNII: PDC6A3C0OX)
hexyl laurate (UNII: 4CG9F9W01Q)
aloe vera leaf (UNII: ZY81Z83H0X)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
medium-chain triglycerides (UNII: C9H2L21V7U)
cetyl alcohol (UNII: 936JST6JCN)
shea butter (UNII: K49155WL9Y)
panthenol (UNII: WV9CM0O67Z)
magnesium aspartate (UNII: R17X820ROL)
zinc gluconate (UNII: U6WSN5SQ1Z)
jojoba oil (UNII: 724GKU717M)
tocopherol (UNII: R0ZB2556P8)
copper gluconate (UNII: RV823G6G67)
hyaluronate sodium (UNII: YSE9PPT4TH)
palmitoyl pentapeptide-4 (UNII: KK181SM5JG)
ethylhexylglycerin (UNII: 147D247K3P)
allantoin (UNII: 344S277G0Z)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
lecithin, soybean (UNII: 1DI56QDM62)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
green tea leaf (UNII: W2ZU1RY8B0)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55789-0101-1	60 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/10/2012

Labeler - Mineral Fusion brands (831770032)