FDA.reportPublic FDA data

Instant Radiance Sun Defense

Manufacturer
Dr. Dennis Gross Skincare, LLC | ACUPAC PACKAGING INC | PhytogenX, Inc.
Effective date
2019-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:52:16

Label at a glance#

ProductInstant Radiance Sun Defense Sunscreen Broad Spectrum SPF 40 (Light - Medium) with sheer color correction technology
Active ingredientTITANIUM DIOXIDE, 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

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: 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 includi...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 4.9%Sunscreen
Zinc Oxide 4.42%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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: 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. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Glycerin, Butylene Glycol, Isononyl Isononanoate, Pentylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, C12-15 Alkyl Benzoate, Coconut Alkanes, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ascorbyl Glucoside, Melatonin, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Nordihydroguaiaretic Acid, Sodium Hyaluronate, Palmitoyl Tripeptide-38, Echium Plantagineum Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Boerhavia Diffusa Root Extract, Phospholipids, Sphingolipids, Saccharide Isomerate, Citrus Aurantium Dulcis (Orange) Flower Extract, Glycolic Acid, Sodium PCA, Oleanolic Acid, PEG-60 Almond Glycerides, Hydrogenated Lecithin, Acrylates/Carbamate Copolymer, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Coco-Caprylate/Caprate, Aluminum Hydroxide, Xanthan Gum, Citric Acid, Disodium EDTA, Hydroxypropyl Cyclodextrin, Sodium Citrate, Caprylyl Glycol, Isohexadecane, Polyhydroxystearic Acid, Sodium Hydroxide, Tromethamine, BHT, Polysorbate 60, Carbomer, Isopropyl Titanium Triisostearate, Sorbitan Isostearate, Stearic Acid, Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citrus Aurantium Dulcis (Orange) Oil, [+/- (May Contain): Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499)]

Questions?

OTC - QUESTIONS SECTION

Call 1-888-830-7546 Monday through Friday, 9:00 AM to 5:00 PM EST

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Light - Medium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

SKINCARE

NO
CHEMICAL
FILTERS

SKINCARE

Dr Dennis Gross

instant radiance
sun defense

Sunscreen
Broad Spectrum
SPF 40

with sheer color
correction technology

1.7 fl oz/50ml e

LIGHT – MEDIUM

Dr Dennis Gross

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Light - Medium
PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Light - Medium

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Medium - Deep

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

SKINCARE

NO
CHEMICAL
FILTERS

SKINCARE

Dr Dennis Gross

instant radiance
sun defense

Sunscreen
Broad Spectrum
SPF 40

with sheer color
correction technology

1.7 fl oz/50ml e

MEDIUM - DEEP

Dr Dennis Gross

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Medium - Deep
PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Medium - Deep

Products#

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

DailyMed product names page 1 of 2 · 64 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58633-35658633-356-10, 58633-356-40
58633-35758633-357-10, 58633-357-40

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 121 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
PENTYLENE GLYCOL50C1307PZGIACT
SAFFLOWER OIL65UEH262ISIACT
OLIVE OIL6UYK2W1W1EIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
COCONUT ALKANES1E5KJY107TIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
MELATONINJL5DK93RCLIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MASOPROCOL7BO8G1BYQUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PALMITOYL LYSYLDIOXYMETHIONYLLYSINET7A529FB8OIACT
ECHIUM PLANTAGINEUM SEED OILPIB7XBU8XWIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
BOERHAVIA DIFFUSA ROOTKR0SR09KYLIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SACCHARIDE ISOMERATEW8K377W98IIACT
CITRUS SINENSIS FLOWERH02N5LQ5F6IACT
GLYCOLIC ACID0WT12SX38SIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
OLEANOLIC ACID6SMK8R7TGJIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMERR0R8I3X29JIACT
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE7D4Q5YJ8NVIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOHEXADECANE918X1OUF1EIACT

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
99829265-a77a-6d51-e053-2995a90a6206271a2672-e580-42ce-babe-f850acb240992019-12-12WarningsExact identifier
spl id: 99829265-a77a-6d51-e053-2995a90a6206
spl set id: 271a2672-e580-42ce-babe-f850acb24099

Reported adverse events (FAERS/openFDA)#

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