Sunscreen (Octinoxate, Octisalate, Octocrylene, Oxybenzone) Lotion [Humphreyline] -

SUNSCREEN (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [HUMPHREYLINE]
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ACTIVE INGREDIENT

Octinoxate (6.5%)

Octisalate (4.0%)

Octocrylene (7.0%)

Oxybenzone (5.5%)
PURPOSE

Sunscreen
WARNINGS

For external use only.

Avoid contact with eyes.

Discontinue use if rash or irritation occurs.

Children under 6 months consult a doctor before use.
KEEP OUT OF REACH OF CHILDREN

Children under 6 months consult a doctor before use.
INDICATIONS & USAGE

For external use only.
INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

SUNSCREEN
octinoxate, octisalate, octocrylene, oxybenzone lotion

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)

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)

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