CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45- titanium dioxide, zinc oxide stick

Clear Foundation Sunscreen Broad Spectrum SPF 45 by

Drug Labeling and Warnings

Clear Foundation Sunscreen Broad Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by Eai-jr 286, Inc, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Titanium Dioxide 14% Sunscreen

Zinc Oxide 6% Sunscreen

PURPOSE

• 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
• Higher SPF gives more sunburn protection
• Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
• Provides high protection against sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

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

WARNINGS

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

Stop use and ask a doctor if:

rash or irritation develops and lasts

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Foundation Sunscreen Face Stick

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Color: Clear

11g NET WT. 0.39

INGREDIENTS AND APPEARANCE

CLEAR FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 45 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-012-01	11 g in 1 BOX; Type 0: Not a Combination Product	04/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2018

Labeler - Eai-jr 286, Inc (827896718)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	manufacture(71014-012)