UNSUN BROAD SPECTRUM SPF 15 SUNSCREEN- 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 face Sunscreen 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 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. 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 SPF 30 face sunscreen

Principal Display Label

UNSUN  BROAD SPECTRUM SPF 15 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0306
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
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
CUCUMBER SEED (UNII: BT3S9L53JK)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ROSA CANINA SEED (UNII: 4503R1M9UT)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
LINSEED OIL (UNII: 84XB4DV00W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ALLANTOIN (UNII: 344S277G0Z)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
WATER (UNII: 059QF0KO0R)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SHEA BUTTER (UNII: K49155WL9Y)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0306-344 mL in 1 TUBE; Type 0: Not a Combination Product02/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/21/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028manufacture(58443-0306) , label(58443-0306) , analysis(58443-0306) , pack(58443-0306)

Revised: 10/2020
Document Id: b2316d59-dd9b-579b-e053-2a95a90ac9e8
Set id: b23188b8-01e3-68f2-e053-2a95a90a9c38
Version: 1
Effective Time: 20201021
 
Prime Enterprises Inc.