PURPOSE- octinoxate, octisalate and oxybenzone lotion

PURPOSE by

Drug Labeling and Warnings

PURPOSE by is a Otc medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated, Voyant Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%
Octisalate 5%
Oxybenzone 3%

Purpose

Sunscreen

Use

■ helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert:Spending
time in the sun increases your risk of skin
cancer and early skin aging. This product has
been shown only to help prevent sunburn, not
skin cancer or early skin aging.

For external use only.

Do not use ■ on damaged or broken skin.

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

Stop use and ask a doctor ■ if rash occurs.

Keep out of reach of children.

If product is
swallowed, get medical help or contact a
Poison Control Center right away.

Directions

■ apply generously and evenly 15 minutes
    before sun exposure
■ apply to all skin exposed to the sun
■ use a water resistant sunscreen if
    swimming or sweating
■ reapply at least every 2 hours
■ children under 6 months of age:
   Ask a doctor

Other information

■ protect this product from excessive heat
    and direct sun
■ may stain or damage some fabrics
    or surfaces

Inactive ingredients

water, octyldodecyl neopentanoate, glycerin,
emulsifying wax NF, glyceryl stearate,
PEG-100 stearate, dimethicone,
triethanolamine, diazolidinyl urea, carbomer,
methylparaben, ethylparaben, propylparaben,
bisabolol, farnesol, citric acid

Questions or comments?

Call 1-800-553-5340

Principal Display Panel

PURPOSE ®

Dual
Treatment
Moisture
Lotion

Sunscreen
SPF 10

Oil-Free

Fragrance Free

Provides
Long-Lasting
Moisture

Developed with
Dermatologists

4 OZ (113g)

9474702

INGREDIENTS AND APPEARANCE

PURPOSE 
octinoxate, octisalate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24208-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24208-001-04	1 in 1 CARTON	10/07/2013
1		113 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	10/07/2013

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Voyant Beauty, Inc.		243547333	manufacture(24208-001)