SPF30 SUNSCREEN- octisalate, octisalate, oxybenzone lotion

SPF30 SUNSCREEN by

Drug Labeling and Warnings

SPF30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Shanghai Mengna Personal Care Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Octinoxate 7.5%, Octisalate 2.0%, Oxybenone 4.0% Titanium Dioxide 2.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS:

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

Questions or Comment?

Call toll free 1-888-543-0938

Distributed By:

Event Blossom - Tustin, CA 92780 Made in China

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN 
octisalate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71642-016
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	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71642-016-00	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/06/2017

Labeler - Shanghai Mengna Personal Care Co., Ltd (526931632)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Mengna Personal Care Co., Ltd		526931632	manufacture(71642-016)