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NDC 00187-5500-04 Purpose 76; 50; 30 mg/mL; mg/mL; mg/mL Details

Purpose 76; 50; 30 mg/mL; mg/mL; mg/mL

Purpose is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch Health US LLC. The primary component is OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	00187-5500
Product ID	0187-5500_25ecf41f-85d3-4f2b-9e4d-8ec40d6474d1
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	76; 50; 30
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	OCTINOXATE; OCTISALATE; OXYBENZONE
Labeler Name	Bausch Health US LLC
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 00187-5500-04 (00187550004)

Pricing Information	N/A
NDC Package Code	0187-5500-04
Billing NDC	00187550004
Package	1 BOTTLE, PUMP in 1 CARTON (0187-5500-04) / 118 mL in 1 BOTTLE, PUMP
Marketing Start Date	2013-10-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7dc62571-2ada-4bb3-a9c7-c51d3dced9c6 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/comments?

1-800-321-4576

Package/Label Principal Display Panel – 118 ml Carton

PURPOSE®

Dual Treatment

Moisture Lotion

Sunscreen

SPF 10

Oil-Free

Fragrance Free

Provides

Long-Lasting

Moisture

Developed with

Dermatologists

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

PURPOSE

octinoxate, octisalate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0187-5500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	76 mg in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg in 1 mL

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:0187-5500-04	1 in 1 CARTON	10/07/2013
1		118 mL in 1 BOTTLE, PUMP; 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 Health US LLC (831922468)

Name	Address	ID/FEI	Business Operations
Establishment
KIK Custom Product - Rexdale Plant		243547333	MANUFACTURE(0187-5500)

Revised: 8/2020

Document Id: 25ecf41f-85d3-4f2b-9e4d-8ec40d6474d1

Set id: 7dc62571-2ada-4bb3-a9c7-c51d3dced9c6

Version: 4

Effective Time: 20200819