Suntan Lotion (Octinoxate Oxybenzone Titanium Dioxide) Lotion [Tri-Coastal Design Company Inc. ] -

SUNTAN LOTION (OCTINOXATE OXYBENZONE TITANIUM DIOXIDE) LOTION [TRI-COASTAL DESIGN COMPANY INC. ]
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NDC	49852-201-60
Set ID	68b71261-a795-4df1-b3ee-a165adf4bd89
Category	HUMAN OTC DRUG LABEL
Packager	Tri-Coastal Design Company Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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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, DC Orange 4, Disodium EDTA, FDC Blue 1, FDC Yellow 5, 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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE (UNII: NMQ347994Z)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49852-201-60	60 mL in 1 TUBE

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

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

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

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Medic