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NDC 24208-0001-04 PURPOSE 7.5; 5; 3 g/100g; g/100g; g/100g Details

PURPOSE 7.5; 5; 3 g/100g; g/100g; g/100g

PURPOSE is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	24208-0001
Product ID	24208-001_a21e35cf-e18f-44d7-aa83-ab252094b261
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PURPOSE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Octisalate and Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	7.5; 5; 3
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	OCTINOXATE; OCTISALATE; OXYBENZONE
Labeler Name	Bausch & Lomb Incorporated
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24208-0001-04 (24208000104)

Pricing Information	N/A
NDC Package Code	24208-001-04
Billing NDC	24208000104
Package	1 BOTTLE in 1 CARTON (24208-001-04) / 113 g in 1 BOTTLE
Marketing Start Date	2013-10-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a1e14135-b8da-4cee-8c5b-1893572f4de4 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/07/2013

Labeler - Bausch & Lomb Incorporated (196603781)

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

Revised: 7/2022

Document Id: a21e35cf-e18f-44d7-aa83-ab252094b261

Set id: a1e14135-b8da-4cee-8c5b-1893572f4de4

Version: 2

Effective Time: 20220705