FDA.reportPublic FDA data

sunbetter TONE SMART SPF 75 Sunscreen Lotion

Manufacturer
SKINBETTER SCIENCE LLC
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:50:59

Label at a glance#

Productsunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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 libera...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.5%

Zinc Oxide 10.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

800-538-5600

Principal Display Panel

PACKAGE LABEL.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)

PDPPDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73291-0003-1sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart50 mL in 1 BOTTLE, PUMPLOTION505
73291-0003-2sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart15 mL in 1 BOTTLE, PUMPLOTION155
73291-0003-3sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart1 mL in 1 PACKETLOTION15
73291-0003-4sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart237 mL in 1 BOTTLE, PUMPLOTION2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73291-0003SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [SKINBETTER SCIENCE LLC]5Current NDC, Legacy NDC, 4 package rows20250108_b878ee3b-6897-3c4a-e053-2995a90afed7.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73291-000373291-0003-1, 73291-0003-2, 73291-0003-3, 73291-0003-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GINGERC5529G5JPQIACT
ALLANTOIN344S277G0ZIACT
ALUMINUM OXIDELMI26O6933IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
STARCH, CORNO8232NY3SJIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
UBIDECARENONEEJ27X76M46IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DODECAMETHYLPENTASILOXANE0QDQ2VQ5YJIACT
OPUNTIA FICUS-INDICA STEMMUD8892KHLIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
SQUALANEGW89575KF9IACT
STEARIC ACID4ELV7Z65APIACT
CAPER BERRY7G4C45EE8CIACT
CETYL DIMETHICONE 45IK315POC44IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CERIC OXIDE619G5K328YIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HIMANTHALIA ELONGATA21RND18XRRIACT
MICAV8A1AW0880IACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE RED1K09F3G675IACT
BLACK OLIVE2M6QWV94OCIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
PANTHENOLWV9CM0O67ZIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT

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
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
ndc (package): 73291-0003-2
ndc (package): 73291-0003-4
ndc (package): 73291-0003-1
ndc (package): 73291-0003-3
ndc (product): 73291-0003
ndc11 (package): 73291000301
ndc11 (package): 73291000302
ndc11 (package): 73291000303
ndc11 (package): 73291000304
spl id: 2b1332b5-b97e-aa0e-e063-6294a90adb21
spl set id: b878ee3b-6897-3c4a-e053-2995a90afed7

Reported adverse events (FAERS/openFDA)#

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