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

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by INNOVATION SPECIALTIES, Ningbo Dowland Daily Health Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Octinoxate 7.5 %

Oxybenzone 4.0 %

Octisalate 2.0 %

Titanium Dioxide 2.5%

PURPOSE

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• Non-Water Resistant Product.
  
• Apply liberally 15 minutes before sun exposure.
  
• Reapply at least every 2 hours.
  
• Children under 6 months : Ask a doctor
  

WARNINGS

Warnings:

This product has been shown only to prevent sunburn NOT skin cancer or early skin aging.

For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Dosage and Administration

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Children under 6 months : Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

C12-15 Alkyl Benzoate, Ceteareth-25, Cetearyl Alcohol, Disodium EDTA, Glycerin, Glyceryl

Stearate, Myristyl Propionate, PEG-15 Cocomonium Chloride, PEG-9 Dimethicone,

Propylene Glycol Dioleate, Water, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARETH-25 (UNII: 8FA93U5T67)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MYRISTYL PROPIONATE (UNII: P59053E7NJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PEG-9 DIMETHICONE (UNII: 9OZ27X065D)
PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-204-03	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/05/2013

Labeler - INNOVATION SPECIALTIES (030837314)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Dowland Daily Health Co., Ltd		421264675	manufacture(76138-204)