Instant Radiance Sun Defense

Instant Radiance Sun Defense by

Drug Labeling and Warnings

Instant Radiance Sun Defense by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare, LLC, PhytogenX, Inc., ACUPAC PACKAGING INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTANT RADIANCE SUN DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40 (LIGHT - MEDIUM) WITH SHEER COLOR CORRECTION TECHNOLOGY- titanium dioxide and zinc oxide cream 
INSTANT RADIANCE SUN DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40 (MEDIUM-DEEP) WITH SHEER COLOR CORRECTION TECHNOLOGY- titanium dioxide and zinc oxide cream 
Dr. Dennis Gross Skincare, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Instant Radiance Sun Defense

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 4.9%Sunscreen
Zinc Oxide 4.42%Sunscreen

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.

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

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

Inactive ingredients

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?

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

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 - Medium - Deep

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
INSTANT RADIANCE SUN DEFENSE  SUNSCREEN BROAD SPECTRUM SPF 40 (LIGHT - MEDIUM) WITH SHEER COLOR CORRECTION TECHNOLOGY
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58633-356
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE49 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE44.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
MELATONIN (UNII: JL5DK93RCL)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TROMETHAMINE (UNII: 023C2WHX2V)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ORANGE OIL (UNII: AKN3KSD11B)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SOY SPHINGOLIPIDS (UNII: P491F5HP1U)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58633-356-101 in 1 CARTON06/03/2016
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 58633-356-402 mL in 1 PACKET; Type 0: Not a Combination Product06/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/03/2016
INSTANT RADIANCE SUN DEFENSE  SUNSCREEN BROAD SPECTRUM SPF 40 (MEDIUM-DEEP) WITH SHEER COLOR CORRECTION TECHNOLOGY
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58633-357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE49 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE44.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
MELATONIN (UNII: JL5DK93RCL)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TROMETHAMINE (UNII: 023C2WHX2V)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ORANGE OIL (UNII: AKN3KSD11B)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58633-357-101 in 1 CARTON06/03/2016
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 58633-357-402 mL in 1 PACKET; Type 0: Not a Combination Product06/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/03/2016
Labeler - Dr. Dennis Gross Skincare, LLC (008190808)
Establishment
NameAddressID/FEIBusiness Operations
ACUPAC PACKAGING INC037138013pack(58633-356, 58633-357)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772manufacture(58633-356, 58633-357) , pack(58633-356, 58633-357)

Revised: 12/2019
 
Dr. Dennis Gross Skincare, LLC