BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel

Bain de Soleil by

Drug Labeling and Warnings

Bain de Soleil by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Octinoxate 2.5%

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

• to open, use pointed end on cap to puncture seal
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor

Other information

• store between 20˚ to 25˚C (68˚ to 77˚F)
• protect this product from excessive heat and direct sun

• may stain or damage some fabrics or surfaces

Inactive ingredients

Mineral Oil, Petrolatum, Paraffin, Ozokerite, Isopropyl Myristate, Hydrogenated Vegetable Oil, Fragrance, Propylparaben, Tocopherol (Vitamin E), D&C Yellow No. 10 Aluminum Lake, D&C Red No. 17

Questions?

866-288-3330

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Distributed by

Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 88 g Tube Carton

SPF

4

BAIN de

SOLEIL ®

SUNSCREEN

ORANGE GELÉE ®

Classic Formula

Luxurious Emollients

NET WT 3.12 OZ (88g)

INGREDIENTS AND APPEARANCE

BAIN DE SOLEIL  ORANGE GELEE SPF 4
octinoxate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 17 (UNII: ND733RX3JN)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7189-1	1 in 1 CARTON	05/21/1999
1		88 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/21/1999

Labeler - Bayer HealthCare LLC (112117283)