UNSUN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion 
Prime Enterprises, Inc.

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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Unsun Mineral Tinted Face Sunscreen Lotion Broad Spectrum SPF 30

Active ingredients

Titanium Dioxide 3%

Zinc Oxide 3%

Purpose

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

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.

Directions

Apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

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 suncreen 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. to 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor.

Inactive ingredients

Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other information

protect this product from excessive heat and direct sun.

Questions or comments?

info@unsuncosmetics.com

Unsun Mineral Tinted Face Sunscreen Lotion Broad Spectrum SPF 30

Principal Display Label

UNSUN  BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0389
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE31.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LINSEED OIL (UNII: 84XB4DV00W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SHEA BUTTER (UNII: K49155WL9Y)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ROSA CANINA SEED (UNII: 4503R1M9UT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ALLANTOIN (UNII: 344S277G0Z)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CUCUMBER SEED (UNII: BT3S9L53JK)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
Product Characteristics
Colorbrown (Medium Tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0389-350 mL in 1 TUBE; Type 0: Not a Combination Product02/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/16/2021
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(58443-0389) , label(58443-0389) , analysis(58443-0389) , pack(58443-0389)

Revised: 1/2021
Document Id: b8f1f8f3-4efb-49eb-e053-2995a90aef25
Set id: b8f1e9e6-2bde-79d1-e053-2995a90ac016
Version: 1
Effective Time: 20210115
 
Prime Enterprises, Inc.