SPF 60 MINERAL SUNSCREEN- titanium dioxide, zinc oxide stick 
Derma Care Research Labs, LLC

----------

Aruba SPF 60 Sunscreen Stick

Titanium Dioxide 6%, Zinc Oxide 4.6%

Sunscreen

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.

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 or irritation develops and lasts.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Apply liberally 15 minutes before sun exposure and as needed. Reapply

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 value of 15 or higher and other sun protection measures including:

Aluminum hydroxide, beeswax, BHT, butyloctyl salicylate, C12-15 alkyl benzoate, cetyl alcohol, dimethicone, euphoria cerifera (candelilla) wax, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, polyethylene, stearic acid, triethoxycaprylysilane

LabelLabelLabel

SPF 60 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-547
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CANDELILLA WAX (UNII: WL0328HX19)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
CERESIN (UNII: Q1LS2UJO3A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PARAFFIN (UNII: I9O0E3H2ZE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-547-0114 g in 1 CYLINDER; Type 0: Not a Combination Product05/23/2023
2NDC:72839-547-1114 g in 1 CYLINDER; Type 0: Not a Combination Product05/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/23/2023
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(72839-547)

Revised: 11/2023
Document Id: 0aae69f1-66c0-a199-e063-6394a90a3d75
Set id: 0aae69f1-66bf-a199-e063-6394a90a3d75
Version: 1
Effective Time: 20231121
 
Derma Care Research Labs, LLC