SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART- zinc oxide, titanium dioxide lotion

sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart by

Drug Labeling and Warnings

sunbetter Broad Spectrum SPF 75 Sunscreen 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 3.5%

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

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.

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.

Inactive ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Allantoin, Alumina, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Bisabolol, Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Capparis Spinosa Fruit Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetyl Dimethicone, Dimethicone, Disteardimonium Hectorite, Glycerin, Himanthalia Elongata Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Mica, Niacinamide, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Opuntia Ficus-Indica Stem Extract, Panthenol, Phenethyl Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyglyceryl-3 Sorbityl Linseedate, Polyglyceryl-4 Oleate, Polygonum Aviculare Extract, Polyhydroxystearic Acid, Polymethyl Methacrylate, Potassium Sorbate, Silica, Sodium Benzoate, Sodium Chloride, Squalane, Stearic Acid, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethyl Citrate, Tropolone, Ubiquinone, Water, Zea Mays (Corn) Starch, 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

sunbetter™

Advanced Mineral Protection

BROAD SPECTRUM SPF 75

SUNSCREEN LOTION

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science®

1.7 FL.OZ. (50 ML)

INGREDIENTS AND APPEARANCE

SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73291-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GINGER (UNII: C5529G5JPQ)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STARCH, CORN (UNII: O8232NY3SJ)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
UBIDECARENONE (UNII: EJ27X76M46)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPER BERRY (UNII: 7G4C45EE8C)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CERIC OXIDE (UNII: 619G5K328Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
MICA (UNII: V8A1AW0880)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BLACK OLIVE (UNII: 2M6QWV94OC)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
PANTHENOL (UNII: WV9CM0O67Z)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TROPOLONE (UNII: 7L6DL16P1T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73291-0003-1	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021
2	NDC: 73291-0003-2	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021
3	NDC: 73291-0003-3	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2021
4	NDC: 73291-0003-4	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2021

Labeler - SKINBETTER SCIENCE LLC (049403602)