URBAN ANTIOXIDANT SUNSCREEN SPF 40- homosalate, octisalate, octocrylene, zinc oxyide cream cream 
Dr. Loretta, LLC

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Urban Antioxidant Sunscreen SPF 40

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%


Sunscreen

Use

Helps prevent sunburn.

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 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 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.






Urban Box

Sample Packet

URBAN ANTIOXIDANT SUNSCREEN SPF 40 
homosalate, octisalate, octocrylene, zinc oxyide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71501-1902
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71501-1902-150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2019
2NDC:71501-1902-21.5 mL in 1 PACKET; Type 0: Not a Combination Product09/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/16/2019
Labeler - Dr. Loretta, LLC (609417121)
Registrant - Dr. Loretta, LLC (609417121)

Revised: 12/2023
Document Id: 0c868857-d5b1-9413-e063-6294a90a0bab
Set id: 930150a3-08bb-17fd-e053-2995a90a786b
Version: 3
Effective Time: 20231215
 
Dr. Loretta, LLC