BAIN DE SOLEIL MEGA TAN SPF 4- octinoxate and octocrylene lotion

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Octinoxate 3.5%, Octocrylene 1%

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

• use sparingly around hairline and eyebrows. Blend completely to avoid streaking. Wash and wipe hands immediately after each application

For Sunscreen Use

• 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

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

• store at or below room temperature

Inactive ingredients

water, butylene glycol, cyclopentasiloxane, polyquaternium-37, mineral oil, PPG-1 trideceth-6, VP/eicosene copolymer, isohexadecane, tribehenin, cetyl palmitate, fragrance, distearyldimonium chloride, aloe barbadensis leaf extract, eucalyptus globulus leaf extract, prunus armeniaca (apricot) fruit extract, chamomilla recutita (matricaria) flower extract, theobroma cacao (cocoa) extract, elaeis guineensis (palm) kernel oil, lanolin, iodopropynyl butylcarbamate, DMDM hydantoin, cetyl alcohol, cetyl hydroxyethylcellulose, disodium EDTA, dihydroxyacetone

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 118 mL Tube Carton

BAIN
de
SOLEIL ®

MEGA TAN ®

4
spf

sunscreen with self tanner

faster, darker tan
contains a self tanner
moisturizers & botanicals

4 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

BAIN DE SOLEIL  MEGA TAN SPF 4
octinoxate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MINERAL OIL (UNII: T5L8T28FGP)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
APRICOT (UNII: 269CJD5GZ9)
CHAMOMILE (UNII: FGL3685T2X)
COCOA (UNII: D9108TZ9KG)
PALM KERNEL OIL (UNII: B0S90M0233)
LANOLIN (UNII: 7EV65EAW6H)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIHYDROXYACETONE (UNII: O10DDW6JOO)

Product Characteristics
Color	white (off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7094-1	1 in 1 CARTON	05/21/1999
1		118 mL 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)