TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50- zinc oxide stick

Transparent Mineral Sunscreen Facestick Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Transparent Mineral Sunscreen Facestick Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Amavara, Inc, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 22.5% Sunscreen

PURPOSE

Uses

• Helps Prevent Sunburn
• Higher SPF gives more sunburn protection
• 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.
• 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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

For external use only

Stop use and ask a doctor if

rash occurs or irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions

Apply liberally and generously 15 minutes before sun exposure and at least
every 2 hours. 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 of 15 or higher and other sun
protection measures including: limit your time in the sun, especially from 10
a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Reapply:
after 80 minutes of swimming or sweating immediately after towel drying
at least every 2 hours.

INACTIVE INGREDIENT

Inactive Ingredients: Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Capylic/Capric Triglyceride, Silica, Ozokerite, Nylon-12, Polyethylene, Dimethicone, Hydrogenated Olive Oil, Olea Europaea (Olive) Oil Unsafonifiables, Dimethicone/Vinyl Dimethicone Crosspolymer Hydrogenated Olive Oil Unsaponifiables, Polyhydroxystearic Acid, Tribehenin, Acrylates/Dimethicone Copolymer, Disteardimonium Hectorie, Polymethyl Methacrylate, Laureth-3, Laureth-25, Helianthus Annuus (Sunflower) Seed Wax, 1,2 Hexanediol, 1,2-Octanediol, Tocopheryl Acetate, Polymethylmethacrylate, Cerium Oxide, Bisabolol, Benzylidene Dimethoxydimethylindanone, Phenethyl Alcohol, Caprylyl Glycol, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract

PRINCIPAL DISPLAY PANEL

Transparent Mineral Sunscreen Facestick

Safe for Sensitive Skin

Water Resistant 80 minutes

Broad Spectrum SPF 50

Net. Wt. 0.6 oz 16.8 g

INGREDIENTS AND APPEARANCE

TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71942-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERIC OXIDE (UNII: 619G5K328Y)
LEVOMENOL (UNII: 24WE03BX2T)
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LAURETH-3 (UNII: F32E4CB0UJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CERESIN (UNII: Q1LS2UJO3A)
NYLON-12 (UNII: 446U8J075B)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
GINGER (UNII: C5529G5JPQ)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
LAURETH-25 (UNII: RPD53041LR)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71942-103-01	16.8 g in 1 BOX; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/12/2018

Labeler - Amavara, Inc (079636282)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	manufacture(71942-103)