FDA.reportPublic FDA data

sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart

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 00:52:41

Label at a glance#

Productsunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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 liber...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.4%

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, 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

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

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

Principal DisplayPrincipal Display

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73291-0001-12024-01-31C16284748780-11030e365-1dd2-111a-e063-dadaa90a10e2sunbetter TONE SMART SPF 68 Sunscreen Compact

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73291-0001-1sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart12 g in 1 CONTAINERSTICK125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73291-0001SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE SMART (ZINC OXIDE, TITANIUM DIOXIDE) STICK [SKINBETTER SCIENCE LLC]5Current NDC, Legacy NDC, 1 package rows20250116_8f119447-045b-43f3-e053-2995a90aea77.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73291-000173291-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CORN OIL8470G57WFMIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
HEXYLDECANOL151Z7P1317IACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HIMANTHALIA ELONGATA21RND18XRRIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
GINGERC5529G5JPQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERIC OXIDE619G5K328YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARIC ACID4ELV7Z65APIACT
TRIBEHENIN8OC9U7TQZ0IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
APRICOT KERNEL OIL54JB35T06AIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAURETH-25RPD53041LRIACT
LAURETH-3F32E4CB0UJIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CERESINQ1LS2UJO3AIACT
DIMETHICONE METHACRYLATE (3000 MW)LO1KC6D3D5IACT
ALUMINUM OXIDELMI26O6933IACT
RAPESEED STEROLB46B6DD20UIACT
DIMETHICONE92RU3N3Y1OIACT
FERRIC OXIDE RED1K09F3G675IACT

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 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
ndc (package): 73291-0001-1
ndc (product): 73291-0001
ndc11 (package): 73291000101
spl id: 2b133173-6c48-1159-e063-6294a90a19f6
spl set id: 8f119447-045b-43f3-e053-2995a90aea77

Reported adverse events (FAERS/openFDA)#

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