OTC Medication Information: Transparent Mineral Sunscreen Facestick Broad Spectrum SPF 50

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.

Active Ingredients Purpose

Zinc Oxide 22.5% Sunscreen

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

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
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primary 1
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primary 2
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 22.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DISTEARDIMONIUM HECTORITE
CERIC OXIDE
LEVOMENOL
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE
ALUMINUM OXIDE
TRIBEHENIN
LAURETH-3
BUTYLOCTYL SALICYLATE
CAPRYLYL GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
OCTYLDODECYL NEOPENTANOATE
MEDIUM-CHAIN TRIGLYCERIDES
SILICON DIOXIDE
CERESIN
NYLON-12
LOW DENSITY POLYETHYLENE
DIMETHICONE
HYDROGENATED OLIVE OIL
POLYHYDROXYSTEARIC ACID (2300 MW)
POLY(METHYL METHACRYLATE; 450000 MW)
1,2-HEXANEDIOL
PHENYLETHYL ALCOHOL
GINGER
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES
HYDROGENATED OLIVE OIL UNSAPONIFIABLES
LAURETH-25
HELIANTHUS ANNUUS SEED WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71942-103-01 16.8 g in 1 BOX None
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 Operations
Northwest Cosmetic Laboratories LLC 929572014 manufacture (71942-103)

Revised: 05/2018 Amavara, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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