SUNSCREEN SPF30- octinoxate, octisalate, oxybenzone, titanium dioxide lotion

SunScreen SPF30 by

Drug Labeling and Warnings

SunScreen SPF30 by is a Otc medication manufactured, distributed, or labeled by Shanghai Kejing Cleaning Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                                                Purpose

Octinoxate 7.8 percent, Octisalate 2.0 percent, Oxybenzone 4 percent

Titanium Dioxide 2.5 percent........................................................................ Sunscreen

PURPOSE

Uses: Helps prevent sunburn

WARNINGS

Warnings: For external use only.

WHEN USING

When using this product:  Avoid contact with eyes, In case of eye contact, flush with plenty of water.

STOP USE

Stop use and ask a doctor if irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center.

DOSAGE & ADMINISTRATION

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

DESCRIPTION

Other information.
Sun Alert: Limiting sun exposure and using sunscreens may
reduce the risk of skin aging, skin cancer, and other harmful
effects of the sun.

SPF30 SUNSCREEN SPRAY

UVAand UVB PROTECTION

Distributed by Tekweld Inc.
180 Central Avenue,
FARMINGDALE,NY11735

made in China          MFG:90807

INACTIVE INGREDIENT

Inactive Ingredients Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate, Disodium EDTA, Glycerin, Ceteareth-25,

Disodium Ethylene Dicocamide PEG-15 Disulfate, Dimethicone, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF30 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31190-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31190-500-60	1 in 1 CARTON
1		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2010

Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)

Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Kejing Cleaning Products Co., Ltd.		526877847	manufacture