FDA.reportPublic FDA data

SUN SAVVY SOLAR SHIELD

Manufacturer
CRC (Cosmoceutical Research Center)
Effective date
2019-02-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:31:55

Label at a glance#

ProductSUN SAVVY SOLAR SHIELD
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

PREVENTION OF SUNBURN, REDUCTION OF SKIN DAMAGE AND PREMATURE AGING CAUSED BY SUN EXPOSURE.

Dosage and administration

APPLY A SMALL AMOUNT EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. ASK A DOCTOR BEFORE USE ON CHILDREN UNDER 6 MONTHS OF AGE. REAPPLY AFTER TOWEL DRYING, SWIMMING OR PERSPIRING.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 5%

TITANIUM DIOXIDE 5%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

PREVENTION OF SUNBURN, REDUCTION OF SKIN DAMAGE AND PREMATURE AGING CAUSED BY SUN EXPOSURE.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT: KEEP OUT OF EYES, RINSE WITH WATER TO REMOVE.

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

DOSAGE & ADMINISTRATION SECTION

APPLY A SMALL AMOUNT EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. ASK A DOCTOR BEFORE USE ON CHILDREN UNDER 6 MONTHS OF AGE. REAPPLY AFTER TOWEL DRYING, SWIMMING OR PERSPIRING.

OTHER INFORMATION

OTHER SAFETY INFORMATION

LIMITING SUN EXPOSURE, WEARING PROTECTIVE CLOTHING AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL AFFECTS OF THE SUN. MAY STAIN FABRIC.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

PURIFIED WATER, CETYL DIMETHICONE COPOLYOL, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, ETHYLHEXYL PALMITATE, ISOHEXADECANE, CAPRIC CAPRYLIC TRIGLYCERIDES, DIMETHICONE, CETYL DIMETHICONE, SODIUM CHLORIDE, SODIUM PCA, PHENOXYETHANOL, ISOPENTYLDIOL, CAPRYLYL GLYCOL, ALLANTOIN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ART dermagenics_solar_shield_FRART dermagenics_solar_shield_FR

ART dermagenics_solar_shield_BKART dermagenics_solar_shield_BK

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66538-00166538-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
HEXYL LAURATE4CG9F9W01QIACT
ETHYLHEXYL PALMITATE2865993309IACT
ISOHEXADECANE918X1OUF1EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPENTYLDIOL19NOL5474QIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT

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
bd251e22-8762-41f1-99e8-a2baa57a89c7f9ce9207-7429-49b2-a6c7-9ae087207f052019-02-03WarningsExact identifier
spl id: bd251e22-8762-41f1-99e8-a2baa57a89c7
spl set id: f9ce9207-7429-49b2-a6c7-9ae087207f05

Reported adverse events (FAERS/openFDA)#

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