SPF 30 Sunscreen Lotion

Drug Labeling and Warnings

Drug Details [pdf]

SUNSCREEN - octinoxate, octisalate, oxybenzone, titanium dioxide lotion 
Crown Products, LLC

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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SPF 30 Sunscreen Lotion

Active Ingredient

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4%, Titanium Dioxide 2.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.

When using this product

Avoid contact with eyes. In case of eye contact, flush with plenty of water.

Stop use and ask a doctor

if irritation or redness develops.

Keep out of reach of chilren

If swallowed, get medical help or contact a Poison Control Center

Directions

Apply generously and evenly before sun exposure. Reapply as needed after towel drying, swimming, or sweating. Ask a doctor before using on children under 6 months.

Other information

Sun Alert: Limiting sun exposure and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate, Disodium EDTA, Glycerin, Ceteareth-25, Disodium Ethlene Dicocamide PEG-15 Disulfate, Dimethicone, Fragrance

Distributed by: CROWN PRODUCTS, LLC

Mobile, AL 36606 * 1-251-665-3627

MADE IN CHINA

SPF 30 Sunscreen Lotion

UVA and UVB Protection

Active Ingredient
Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4%, Titanium Dioxide 2.5%

Purpose
Sunscreen

SUNSCREEN 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52675-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.0 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mL  in 100 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 MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARETH-25 (UNII: 8FA93U5T67)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52675-030-15	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/14/2012

Labeler - Crown Products, LLC (034018234)

Revised: 5/2012

Document Id: ceaec008-c59e-42c3-bedb-69cc38b43a95

Set id: a5c7d73e-d28b-49d1-ab12-be9de306ac80

Version: 1

Effective Time: 20120514