BAIN DE SOLEIL ORANGE CREME SPF 4- octinoxate and oxybenzone lotion
Schering-Plough HealthCare Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BAIN de SOLEIL®

Drug Facts

Active ingredients

Octinoxate 3.5%, Oxybenzone 1.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external use only

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 months of age and older: apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
children under 6 months of age: ask a doctor

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, PEG-8, Aluminum Starch Octenylsuccinate, Isopropyl Laurate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Diazolidinyl Urea, Propylene Glycol, Methylparaben, Propylparaben, Disodium EDTA, Fragrance, Tocopherol (Vitamin E), Triethanolamine,FD&C Yellow No. 6, FD&C Red No. 40.

PRINCIPAL DISPLAY PANEL

BAIN
de
SOLEIL®

ULTRA LIGHT

ORANGE CRÈME

4
spf

sunscreen

elegant crème
oil-free & ultra light
signature fragrance

NET WT 3.5 OZ (99g)

BAIN DE SOLEIL ORANGE CREME SPF 4
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11523-7305
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (Octinoxate)	Octinoxate	35 mg in 1 g
Oxybenzone (Oxybenzone)	Oxybenzone	15 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water
DiazolidinylUrea
Propylene Glycol
Methylparaben
Propylparaben
Edetate Disodium
Alpha-Tocopherol
Trolamine
FD&C Yellow No. 6
FD&C Red No. 40

Product Characteristics
Color	ORANGE (peach colored)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:11523-7305-2	1 in 1 CARTON
1	NDC:11523-7305-1	99 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/21/1999

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 2/2010

Document Id: 8350c500-5cc5-4c77-a41a-c861220e68cf

Set id: d9e15aa2-84b9-4eba-80ab-4e174c62034c

Version: 1

Effective Time: 20100202

Schering-Plough HealthCare Products, Inc.