HYDRATING AND BALANCING MOISTURIZER SPF 15- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Hydrating and Balancing Moisturizer by

Drug Labeling and Warnings

Hydrating and Balancing Moisturizer by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:  Avobenzone 3.00%, Homosalate 3.75%, Octisalate 2.50%, Octocrylene 2.75%, Oxybenzone 2.00%

WHEN USING

When using this product, keep out of eyes.  Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING AND BALANCING MOISTURIZER  SPF 15
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	3.75 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.75 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Stearic Acid (UNII: 4ELV7Z65AP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Panthenol (UNII: WV9CM0O67Z)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Edetate Disodium (UNII: 7FLD91C86K)
Polysorbate 60 (UNII: CAL22UVI4M)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Phenoxyethanol (UNII: HIE492ZZ3T)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Ext. D&C Violet No. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-158-04	1 in 1 CARTON
1		55 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/15/2011

Labeler - Physicians Formula Inc (021261805)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Formula Inc		825048945	manufacture