Drug Facts

SUNSCREEN- octinoxate, octisalate, octocrylene, oxybenzone lotion
Humphreyline

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

Octinoxate (6.5%)

Octisalate (4.0%)

Octocrylene (7.0%)

Oxybenzone (5.5%)

Sunscreen

For external use only.

Avoid contact with eyes.

Discontinue use if rash or irritation occurs.

Children under 6 months consult a doctor before use.

For external use only.

Water, PPG-15 Stearyl Ether Benzoate, Corn Starch modified, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA

1 oz sunscreen

SUNSCREEN
octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:19392-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	55 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
TROLAMINE (UNII: 9O3K93S3TK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYQUATERNIUM-39 (31/40/29 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW) (UNII: 5CO59WNJ6R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description
Packaging
1	NDC:19392-400-03	28 g in 1 BOTTLE, PLASTIC
2	NDC:19392-400-04	44 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2010

Labeler - Humphreyline (122539042)