CLEAR SUNCREEN FACE STICK BROAD SPECTRUM SPF 45- zinc oxide stick

Clear Suncreen Face Stick Broad Spectrum SPF 45 by

Drug Labeling and Warnings

Clear Suncreen Face Stick Broad Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by Eai-jr 286, Inc, Northwest Cosmetic Laboratories L.L.C. DBA Elevation Labs, Idaho. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 22% 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

Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Nonanoate, Theobroma Cacao (Cacao) Seed Butter, Coco-Caprylate, Butyloctyl Salicylate, Beeswax, Euphorbia Cerifera (Candelilla) Wax, polyhydroxystearic Acid, Lauryl Laurate, Mica, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Persea Gratissima (Avocado) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Brassica Campestris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Brain Oil, Tocopherol, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Carthamus Tinctorius (Safflower) Seed Oil, Bisabolol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Aloe Barbadensis Leaf Extract

PRINCIPAL DISPLAY PANEL

Vertra Premium Sunscreen

SPF 45

Premium Mineral Based

Sunscreen Face Stick

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Color: Clear

11g NET WT. 0.39 OZ

INGREDIENTS AND APPEARANCE

CLEAR SUNCREEN FACE STICK BROAD SPECTRUM SPF 45 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STEARIC ACID (UNII: 4ELV7Z65AP)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
COCOA BUTTER (UNII: 512OYT1CRR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
LAURYL LAURATE (UNII: GPW77G0937)
MICA (UNII: V8A1AW0880)
SHEA BUTTER (UNII: K49155WL9Y)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCONUT OIL (UNII: Q9L0O73W7L)
AVOCADO OIL (UNII: 6VNO72PFC1)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
RICE BRAN OIL (UNII: LZO6K1506A)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
SAFFLOWER OIL (UNII: 65UEH262IS)
LEVOMENOL (UNII: 24WE03BX2T)
ROSEMARY (UNII: IJ67X351P9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-019-01	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 L.L.C. DBA Elevation Labs, Idaho		929572014	manufacture(71014-019)