TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50- zinc oxide stick 
Amavara, 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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Transparent Mineral Sunscreen Facestick SPF 50

Active Ingredients Purpose

Zinc Oxide 22.5% Sunscreen

Uses

Keep out of reach of children

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

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.

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 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

Transparent Mineral Sunscreen Facestick

Safe for Sensitive Skin

Water Resistant 80 minutes

Broad Spectrum SPF 50

Net. Wt. 0.6 oz 16.8 g

secondary

primary 1

primary 2

TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50 
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71942-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71942-103-0116.8 g in 1 BOX; Type 0: Not a Combination Product02/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/12/2018
Labeler - Amavara, Inc (079636282)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Laboratories LLC929572014manufacture(71942-103)

Revised: 5/2018
Document Id: 6bb5f554-1ff3-2285-e053-2a91aa0ae6e3
Set id: 6546625f-d2f4-6c3f-e053-2991aa0a060e
Version: 4
Effective Time: 20180508
 
Amavara, Inc