SPF-40 FACIAL MOISTURIZER- zinc oxide and titanium dioxide lotion 
Mineral Fusion brands

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.

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SPF-40 facial moisturizer

DRUG FACTS

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.

Distributed By:
glōProfessional
Denver, CO 80223

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

SUNSCREEN

glō•therapeutics

SPF 40 Facial
Moisturizer

7.5% Titanium Dioxide,
5% Zinc Oxide,
Peptides

FACIAL SUNSCREEN

Principal Display Panel - 60 mL Tube Carton
SPF-40 FACIAL MOISTURIZER 
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-0101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55789-0101-160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/10/2012
Labeler - Mineral Fusion brands (831770032)

Revised: 4/2013
Document Id: 0eaa0c8d-d12d-4f32-a23b-6c7e6f7b1399
Set id: 5095f202-461d-4008-b6d7-9b73f220f279
Version: 1
Effective Time: 20130405
 
Mineral Fusion brands