SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tekweld Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 7.5%,

Octisalate 5.0%,

Oxybenzone 2.0% 

Titanium Dioxide 2.5%

Soybean oil 3%

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.

Other information

Protect this product from excessive heat and direct sun

Insect Repellent Active Ingredient: Soybean oil 3% Inactive ingredients

Water, Microcrystalline cellulose, C12-15 Alkyl Benzoate, Isooctyl Palmitate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Drug Questions:

877-254-2281

Distributed By:

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71160-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOCETYL PALMITATE (UNII: 355356620Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71160-011-00	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/22/2017

Labeler - Tekweld Solutions, Inc. (029077754)