SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide lotion 
Tekweld Solutions, Inc.

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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SPF 30 Sunscreen lotion

Drug Facts

Active Ingredients

Octinoxate 7.5%,

Octisalate 2.0%,

Oxybenzone 4.0% 

Titanium Dioxide 2.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging.
This products has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Inactive ingredients

Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Other information

Protect this product from excessive heat and direct sun

Drug Questions:

877-254-2281

Distributed By:

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

Label

SPF 30 SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71160-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MYRISTYL PROPIONATE (UNII: P59053E7NJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71160-012-0030 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/22/2017
Labeler - Tekweld Solutions, Inc. (029077754)

Revised: 12/2019
Document Id: 9aa44d85-66f8-a888-e053-2a95a90a3b6c
Set id: 3103759f-5656-4abc-85d9-f4e9735ba107
Version: 4
Effective Time: 20191226
 
Tekweld Solutions, Inc.