SUNTAN LOTION- octinoxate oxybenzone titanium dioxide lotion

Suntan Lotion by

Drug Labeling and Warnings

Suntan Lotion by is a Otc medication manufactured, distributed, or labeled by Tri-Coastal Design Company Inc. , Guangzhou St Eva Fine Chemical Co Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octyl Methoxycinnamate 7%

Oxybenzone 6%

Titanium Dioxide 1%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
  

Warnings

• Keep out of eyes. If contact occurs, rinse thoroughly with water.
  

Stop use and ask a doctor if

• irritation develops
  

Keep out of reach of children

• If swallowed, get medical help promptly or contact Poison Control immediately.

Directions

• Apply generously and evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Ask doctor before use on children under 6 months of age
  

Inactive Ingredients

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cylcomethicone, Disodium EDTA, Fragrance, Glycerin, Imidazolidinyl Urea, Isopropyl Myristate, Methylparaben, Potassium Cetyl Phosphate, Propylparaben, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Package Label

Package Label

INGREDIENTS AND APPEARANCE

SUNTAN LOTION 
octinoxate oxybenzone titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49852-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49852-200-60	60 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2010

Labeler - Tri-Coastal Design Company Inc. (609734900)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou St Eva Fine Chemical Co Ltd		528039793	manufacture