FDA.reportPublic FDA data

Smart Care ® Mineral-Enhanced SUNSCREEN SPRAY

Manufacturer
Ashtel Studios, Inc.
Effective date
2026-10-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-20 03:02:46

Label at a glance#

ProductSmart Care Mineral-Enhanced SUNSCREEN SPF 50
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, 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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure • Hold can 4-6 inches away from the skin to apply • Do not spray directly into the face. Spray into hands then apply to the face  • Do not apply in windy conditions • Use in a well-ventilated area • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age:...

Storage and handling

• protect this product from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.0%
Octisalate 3.0%
Octocrylene 6.0%
Zinc Oxide 7.3%

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

Flammable:
• do not use near heat, flame or while smoking
• avoid long term storage above 104°F (40°C)

Do not use • on damaged or broken skin.

When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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, call Poison Help at 1-800-222-1222 or go to PoisonHelp.org 

Directions

DOSAGE & ADMINISTRATION SECTION

• Spray liberally and spread evenly by hand 15 minutes before sun exposure • Hold can 4-6 inches away from the skin to apply • Do not spray directly into the face. Spray into hands then apply to the face 
• Do not apply in windy conditions • Use in a well-ventilated area
• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
• children under 6 months of age: Ask a doctor
• 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. to 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses

Other information

STORAGE AND HANDLING SECTION

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butane, Isobutane, Propane, Aqua (Water), Isododecane, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Propylene Glycol, Phenoxyethanol, Stearic Acid, Polyglyceryl-10 Myristate, Dimethicone, Triethanolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

UVA/UVB PROTECTION

BROAD SPECTRUM

Water Resistant (80 Minutes)

DESIGNED IN U.S.A.

MADE IN INDIA

SmartCare®
WWW.SMARTCAREUS.COM
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MineralEnhancedSunscreenSprayMineralEnhancedSunscreenSpray

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810147888146GTIN-13: 0810147888146
EAN-13: 0810147888146
GTIN-12: 810147888146
UPC-A: 810147888146
GTIN storage (14 digits): 00810147888146		70108271-3.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-27170108-271-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
BUTANE6LV4FOR43RIACT
ISOBUTANEBXR49TP611IACT
PROPANET75W9911L6IACT
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
POLYGLYCERYL-10 MYRISTATEY9WL8QN3ZBIACT
DIMETHICONE92RU3N3Y1OIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-02full-release2026-06-01 01:37:03
12025-11-26monthly-update2026-06-03 17:45:14

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
6e8314c0-03b3-4eed-be85-35fb4b343339d68048b5-219c-414a-918f-b063b44fe7b52026-02-02WarningsExact identifier
spl set id: d68048b5-219c-414a-918f-b063b44fe7b5

Reported adverse events (FAERS/openFDA)#

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