OTC Medication Information: Sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer

SUNBETTER BROAD SPECTRUM SPF 56 SUNSCREEN STICK SHEER- zinc oxide and titanium dioxide stick
SKINBETTER SCIENCE LLC

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.

Drug Facts

Active ingredients

Titanium Dioxide 5.0%

Zinc Oxide 10.0%

Purpose

Sunscreen

Uses

  • 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.

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If prodoct is swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply:
  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun ircreases 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 time in the sun, especially from 10 a.m. — 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetylhydroxyproline Palmitamide, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Hexyldecanol, Himanthalia Elongata Extract, Hydrogenated Vegetable Oil, Laureth-25, Laureth-3, Octyldodecyl Neopentanoate, Ozokerite, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyethylene, Polyhydroxystearic Acid, Polymethyl Methacrylate, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simethicone, Sodium Chloride, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Water, Zingiber Officinale (Ginger) Root Extract.

Other information

Protect this product from excessive heat and direct sun.

Questions or comments?

800-538-5600

Principal Display Panel

sunbetterâ„¢
Advanced Mineral Protection

BROAD SPECTRUM

SPF 56

SUNSCREEN STICK

SHEER

Water-Resistant (80 Minutes)
Mineral Actives

skinbetter science ®

Net wt. 0.70 oz (20 g)

Label
(click image for full-size original)
SUNBETTER BROAD SPECTRUM SPF 56 SUNSCREEN STICK SHEER
zinc oxide, titanium dioxide stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73291-0002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 100 mg in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
RAPESEED STEROL
BUTYLOCTYL SALICYLATE
CETYLHYDROXYPROLINE PALMITAMIDE
LAURETH-25
PHENOXYETHANOL
POLY(METHYL METHACRYLATE; 450000 MW)
.ALPHA.-TOCOPHEROL, DL-
PHENYL TRIMETHICONE
HIGH DENSITY POLYETHYLENE
SILICON DIOXIDE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
POLYHYDROXYSTEARIC ACID (2300 MW)
1,2-HEXANEDIOL
DIMETHICONE METHACRYLATE (3000 MW)
HIMANTHALIA ELONGATA
CORN OIL
LAURETH-3
CERESIN
PHENYLETHYL ALCOHOL
APRICOT KERNEL OIL
SODIUM CHLORIDE
STEARIC ACID
ALPHA-TOCOPHEROL ACETATE
TRIBEHENIN
WATER
GINGER
ETHYLHEXYLGLYCERIN
.ALPHA.-BISABOLOL, (+/-)-
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL GLYCOL
CERIC OXIDE
DIMETHICONE
HEXYLDECANOL
DISTEARDIMONIUM HECTORITE
OCTYLDODECYL NEOPENTANOATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73291-0002-1 20 g in 1 CONTAINER None
2 NDC:73291-0002-2 6 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/17/2019
Labeler — SKINBETTER SCIENCE LLC (049403602)

Revised: 01/2021 SKINBETTER SCIENCE LLC

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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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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