SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE SMART- zinc oxide, titanium dioxide stick

sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart by

Drug Labeling and Warnings

sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart by is a Otc medication manufactured, distributed, or labeled by SKINBETTER SCIENCE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredients

Titanium Dioxide 8.4%

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 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.
• use a water resistant sunscreen if swimming or sweating.
• 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 time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months of age: 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, Iron Oxides (CI 77491, CI 77492, CI 77499), Laureth-25, Laureth-3, Mica, 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, Triethoxycaprylylsilane, 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

sun better™
Advanced Mineral Protection

BROAD SPECTRUM SPF 68
SUNSCREEN COMPACT

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives
skinbetter science ®
Net wt. 0.42 oz (12g)

Peel Here

INGREDIENTS AND APPEARANCE

SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE SMART 
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73291-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	84 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERIC OXIDE (UNII: 619G5K328Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURETH-25 (UNII: RPD53041LR)
LAURETH-3 (UNII: F32E4CB0UJ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHICONE METHACRYLATE (3000 MW) (UNII: LO1KC6D3D5)
ALUMINUM OXIDE (UNII: LMI26O6933)
RAPESEED STEROL (UNII: B46B6DD20U)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CERESIN (UNII: Q1LS2UJO3A)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICA (UNII: V8A1AW0880)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GINGER (UNII: C5529G5JPQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CORN OIL (UNII: 8470G57WFM)
HEXYLDECANOL (UNII: 151Z7P1317)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73291-0001-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product	09/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/03/2019

Labeler - SKINBETTER SCIENCE LLC (049403602)