SUNTAN LOTION - octinoxate oxybenzone titanium dioxide lotion
Tri-Coastal Design Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

SUNTAN LOTION
octinoxate oxybenzone titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49852-201
Route of Administration	TOPICAL

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