Transparent Mineral Sunscreen Facestick Broad Spectrum SPF 50

Manufacturer
Amavara, Inc | Northwest Cosmetic Laboratories LLC
Effective date
2018-05-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:55:27

Label at a glance#

ProductTransparent Mineral Sunscreen Facestick Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Zinc Oxide 22.5% Sunscreen

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

WARNINGS SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.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

secondarysecondary

primary 1primary 1

primary 2primary 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71942-103-012020-01-31C16284748780-19d75b9cf-ce54-f424-e053-dadaa90a57ceTransparent Mineral Sunscreen Facestick SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71942-103-01Transparent Mineral Sunscreen Facestick Broad Spectrum SPF 5016.8 g in 1 BOXSTICK16.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71942-103TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50 (ZINC OXIDE) STICK [AMAVARA, INC]4Legacy NDC, 1 package rows20180508_6546625f-d2f4-6c3f-e053-2991aa0a060e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71942-10371942-103-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6bb5f554-1ff3-2285-e053-2a91aa0ae6e36546625f-d2f4-6c3f-e053-2991aa0a060e2018-05-08WarningsExact identifier
spl id: 6bb5f554-1ff3-2285-e053-2a91aa0ae6e3
spl set id: 6546625f-d2f4-6c3f-e053-2991aa0a060e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.