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

SPF 30 SUNSCREEN by

Drug Labeling and Warnings

SPF 30 SUNSCREEN 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 Ingredients

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

Titanium Dioxide 2.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses: Helps prevent sunburn

WARNINGS

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun

increase your risk of skin cancer and early skin aging.

this product had been shown only to prevent sunburn,

not skin cancer or 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

Keep out of reach of children. If product swallowed, get

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

STORAGE AND HANDLING

Other information

Protect this product from excessive heat and direct sun

QUESTIONS

Questions or Comment? Call toll free 1-877-254-2281

SPL UNCLASSIFIED SECTION

Insect repellent active ingredients: soybean oil  3%

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31190-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)	SOYBEAN OIL	3.0 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.0 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31190-330-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2016
2	NDC: 31190-330-02	60 g in 1 PACKAGE; Type 0: Not a Combination Product	06/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/25/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Kejing Cleaning Products Co., Ltd.		526877847	manufacture(31190-330)