Tan Smart Mineral Sunscreen

Manufacturer
I Shay Cosmetics Inc
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:37:16

Label at a glance#

ProductSunplus Sunscreen Yosemite SPF 45
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Storage and handling

OTHER iNFORMATION Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 9.75%, OCTINOXATE 7.5%, OCTISALATE 5%

OTC - PURPOSE SECTION

Helps prevent sunburn and photodamage - If used as directed with other sun protection measures (See Directions). decreases the risks of skin cancer and early aging caused by the sun.

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.

If swallowed, get medical help or contact poison control center

Keep out of reach of children

INACTIVE INGREDIENT SECTION

Purified Water, Capric/Caprylic, Glycerin, Cetearyl Alcohol, Ceteareth-20, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethilconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Acrylate Copolymer, Phenoxyethanol, Ethylhexylglycerin, Helianthus annuus (Sunflower) Seed Oil, Carthamus tinctorius (Safflower) Seed Oil, Vitis vinifera (Grape) Seed Oil, Allantoin, Hyaluronic acid, Oenothera Biennis (Evening Primrose) Borago officinalis (Starflower) Oil, Rubus idaeus (Red Raspberry) Seed Oil, Bisobolol (Chamomile)

DOSAGE & ADMINISTRATION SECTION

Apply liberally to dry skin 15 minutes before sun exposure *Reapply to dry skin after 80 minutes of swimming or sweating *immediately after towel drying * at least every 2 hours * Children under 6 months ask a doctor

STORAGE AND HANDLING SECTION

OTHER iNFORMATION Protect the product in this container from excessive heat and direct sun.

OTHER SAFETY INFORMATION

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 10a.m. – 2 p.m. * Wear long-sleeved shirts, pants, hats, and sunglasses

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65112-264-012024-01-30C16284748780-11030e365-124a-111a-e063-dadaa90a10e2Sunplus Face + Body Sunscreen Yosemite SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-264-01Sunplus Sunscreen Yosemite SPF 45136 g in 1 TUBELOTION13611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-264SUNPLUS SUNSCREEN YOSEMITE SPF 45 (SUNSCREEN) LOTION [I SHAY COSMETICS INC]11Legacy NDC, 1 package rows20210126_92dd6756-c458-bbbe-e053-2a95a90a24f5.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65112-26465112-264-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
b9bdc39e-8ea6-615c-e053-2a95a90afe1b92dd6756-c458-bbbe-e053-2a95a90a24f52021-01-25WarningsExact identifier
spl id: b9bdc39e-8ea6-615c-e053-2a95a90afe1b
spl set id: 92dd6756-c458-bbbe-e053-2a95a90a24f5

Reported adverse events (FAERS/openFDA)#

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