CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45- titanium dioxide, zinc oxide stick 
Eai-jr 286, 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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Vertra Clear Foundation Sunscreen Face Stick Broad Spectrum SPF 45

Active Ingredients Purpose

Titanium Dioxide 14% Sunscreen

Zinc Oxide 6% Sunscreen

Keep out of reach of children:

If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

apply liberally and evenly 15 minutes before sun exposure and and at least every 2 hours
reapply: after 80 minutes of swimming or sweating

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 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
immediately after towel drying

Stop use and ask a doctor if:

rash or irritation develops and lasts

Inactive Ingredients

Water, Dimethicone, Caprylic/Capric Triglyceride, Alumina, Lecithin, Stearic Acid, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Squalane, Paraffin, Ceresin, Isononoyl Isononanoate, Microcrystalline Wax, Glycerin, Isopentyldiol, Polyethylene, HDI/Trimethylol Hexyllactone Crosspolymer, Polyglyceryl-6 Polyricinoleate, PEG-10 Dimethicone, Phenxoyethanol, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Triethoxycaprylylsilane, Disodium EDTA, Silica, Tocopherol.

Vertra Elemental Resistance

Foundation Sunscreen Face Stick

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Color: Clear

11g NET WT. 0.39

Invisible stick updated art

Invisible stick updated art primary

CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ISOPENTYLDIOL (UNII: 19NOL5474Q)  
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CERESIN (UNII: Q1LS2UJO3A)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SQUALANE (UNII: GW89575KF9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71014-012-0111 g in 1 BOX; Type 0: Not a Combination Product04/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2018
Labeler - Eai-jr 286, Inc (827896718)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Laboratories LLC929572014manufacture(71014-012)

Revised: 3/2020
Document Id: a0ab36c7-e274-08d4-e053-2a95a90a33b6
Set id: 6a12f44c-3bdc-300f-e053-2a91aa0a4d11
Version: 8
Effective Time: 20200312
 
Eai-jr 286, Inc