Label: SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 GOLDEN HOUR- octisalate, zinc oxide cream
SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 DAY DREAM- octisalate, zinc oxide cream
SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 SUNSET- octisalate, zinc oxide cream
- NDC Code(s): 75936-302-01, 75936-303-01, 75936-304-01
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
apply generously and evenly 15 minutes before sun exposure
reapply at least every 2 hours
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 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
Children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients
Isododecane, Mica, Titanium Dioxide, Polymethylsilsesquioxane/Silica Crosspolymer, Polyethylene,
Caprylyl Methicone, Iron oxides, C18-38 Alkyl Hydroxystearoyl Stearate, Polyhydroxystearic Acid,
Dimethicone, Trimethylsiloxysilicate, Silica, VP/Eicosene Copolymer, Polyglyceryl-3 Polyricinoleate,
Polyglyceryl-3 Diisostearate,Triethoxycaprylylsilane, Norbornene/tris(trimethylsiloxy)silyl-norbornene
Copolymer, Tin Oxide, Helianthuus Annuus (Sunflower) Seed Oil, Jasminum Officinale (Jasmine) Flower
Extract, Rose Extract, Tocopherol. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 GOLDEN HOUR
octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FERRIC OXIDE RED (UNII: 1K09F3G675) ISODODECANE (UNII: A8289P68Y2) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) .DELTA.-TOCOPHEROL (UNII: JU84X1II0N) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-302-01 5 g in 1 JAR; Type 0: Not a Combination Product 01/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/24/2019 SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 DAY DREAM
octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) .DELTA.-TOCOPHEROL (UNII: JU84X1II0N) FERRIC OXIDE RED (UNII: 1K09F3G675) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER OIL (UNII: 3W1JG795YI) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISODODECANE (UNII: A8289P68Y2) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-303-01 5 g in 1 JAR; Type 0: Not a Combination Product 01/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/24/2019 SHIMMERSHADE BROAD SPECTRUM SUNSCREEN SPF 30 SUNSET
octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) .DELTA.-TOCOPHEROL (UNII: JU84X1II0N) FERRIC OXIDE RED (UNII: 1K09F3G675) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) DIMETHICONE (UNII: 92RU3N3Y1O) SUNFLOWER OIL (UNII: 3W1JG795YI) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISODODECANE (UNII: A8289P68Y2) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-304-01 5 g in 1 JAR; Type 0: Not a Combination Product 01/24/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/24/2019 Labeler - Supergoop, LLC (117061743)
