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

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

Sunscreen

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) HOMOSALATE4 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mg  in 50 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 not finalpart35209/16/2019
Labeler - Dr. Loretta, LLC (609417121)
Registrant - Dr. Loretta, LLC (609417121)

Revised: 9/2019
 
Dr. Loretta, LLC