Label: URBAN ANTIOXIDANT SUNSCREEN SPF 40- homosalate, octisalate, octocrylene, zinc oxyide cream cream
- NDC Code(s): 71501-1902-1, 71501-1902-2
- Packager: Dr. Loretta, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 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
- Use
-
INACTIVE INGREDIENT
Water C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions • Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • 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 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 • Children under 6 months of age: Ask a doctor.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
URBAN ANTIOXIDANT SUNSCREEN SPF 40
homosalate, octisalate, octocrylene, zinc oxyide cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71501-1902 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 80 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength STEARETH-2 (UNII: V56DFE46J5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHYTATE SODIUM (UNII: 88496G1ERL) WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARETH-21 (UNII: 53J3F32P58) MICA (UNII: V8A1AW0880) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV) VANILLA (UNII: Q74T35078H) DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F) DIMETHICONE (UNII: 92RU3N3Y1O) COCONUT OIL (UNII: Q9L0O73W7L) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) JOJOBA OIL (UNII: 724GKU717M) FRUCTOSE (UNII: 6YSS42VSEV) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) ORANGE OIL (UNII: AKN3KSD11B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71501-1902-1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/16/2019 2 NDC:71501-1902-2 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 09/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/16/2019 Labeler - Dr. Loretta, LLC (609417121) Registrant - Dr. Loretta, LLC (609417121)
