FDA.reportPublic FDA data

sunbetter SHEER SPF 70 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 70 Sunscreen Sheer
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 libera...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.6%

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, 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, Synthetic Fluorphlogopite, 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 70

SUNSCREEN LOTION

SHEER

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
73291-0004-1sunbetter Broad Spectrum SPF 70 Sunscreen Sheer50 mL in 1 BOTTLE, PUMPLOTION505
73291-0004-2sunbetter Broad Spectrum SPF 70 Sunscreen Sheer15 mL in 1 BOTTLE, PUMPLOTION155
73291-0004-3sunbetter Broad Spectrum SPF 70 Sunscreen Sheer1 mL in 1 PACKETLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73291-0004SUNBETTER BROAD SPECTRUM SPF 70 SUNSCREEN SHEER (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [SKINBETTER SCIENCE LLC]5Current NDC, Legacy NDC, 3 package rows20250108_b879067b-9d7f-3a62-e053-2995a90a9d6b.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73291-000473291-0004-1, 73291-0004-2, 73291-0004-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
NIACINAMIDE25X51I8RD4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINUM OXIDELMI26O6933IACT
HIMANTHALIA ELONGATA21RND18XRRIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CERIC OXIDE619G5K328YIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL DIMETHICONE 45IK315POC44IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
DODECAMETHYLPENTASILOXANE0QDQ2VQ5YJIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SQUALANEGW89575KF9IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
TRIETHYL CITRATE8Z96QXD6UMIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
PANTHENOLWV9CM0O67ZIACT

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 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
ndc (package): 73291-0004-1
ndc (package): 73291-0004-3
ndc (package): 73291-0004-2
ndc (product): 73291-0004
ndc11 (package): 73291000403
ndc11 (package): 73291000402
ndc11 (package): 73291000401
spl id: 2b133456-ffa7-de56-e063-6294a90a18f9
spl set id: b879067b-9d7f-3a62-e053-2995a90a9d6b

Reported adverse events (FAERS/openFDA)#

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