Bain de Soleil

Manufacturer: Bayer HealthCare LLC.
Effective date: 2023-09-08
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 23:56:08

Label at a glance#

ProductBain de Soleil Mega Tan SPF 4

Active ingredientOCTINOXATE, OCTOCRYLENE

Label structure10 sections

Dosage and administration

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

Storage and handling

protect this product from excessive heat and direct sun may stain or damage some fabrics or surfaces store at or below room temperature

Contacts and useful links#

PhoneLabel contact866-288-3330

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.5%, Octocrylene 1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

For Sunscreen Use

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

866-288-3330

PRINCIPAL DISPLAY PANEL - 118 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAIN
de
SOLEIL ^®

MEGA TAN ^®

4
spf

sunscreen with self tanner

faster, darker tan
contains a self tanner
moisturizers & botanicals

4 FL OZ (118mL)

Principal Display Panel - 118 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11523-7094-1	2025-01-30	C162847	48780-1	0191ceaa-6452-198a-e063-dbdaa90aec3e	Bain de Soleil ® Mega Tan ® SPF 4
11523-7094-1	2023-09-08	C162847	48780-1	0191ceaa-6452-198a-e063-dbdaa90aec3e	Bain de Soleil ® Mega Tan ® SPF 4
11523-7094-1	2023-07-28	C162847	48780-1	0191ceaa-6452-198a-e063-dbdaa90aec3e	Bain de Soleil ® Mega Tan ® SPF 4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-7094-1	Bain de SoleilMega Tan SPF 4	1 in 1 CARTON	LOTION	1		7
11523-7094-1	Bain de SoleilMega Tan SPF 4	118 mL in 1 TUBE	LOTION	118		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-7094	BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [BAYER HEALTHCARE LLC.]	7	Legacy NDC, 2 package rows	20230910_6c517222-35fe-4d93-8fc9-bd38ccda65fc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
apricot	INACTIVE INGREDIENT	269CJD5GZ9	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	1
chamomile	INACTIVE INGREDIENT	FGL3685T2X	1
cocoa	INACTIVE INGREDIENT	D9108TZ9KG	1
cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	1
dihydroxyacetone	INACTIVE INGREDIENT	O10DDW6JOO	1
distearyldimonium chloride	INACTIVE INGREDIENT	OM9573ZX3X	1
DMDM hydantoin	INACTIVE INGREDIENT	BYR0546TOW	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
eucalyptus globulus leaf	INACTIVE INGREDIENT	S546YLW6E6	1
iodopropynyl butylcarbamate	INACTIVE INGREDIENT	603P14DHEB	1
isohexadecane	INACTIVE INGREDIENT	918X1OUF1E	1
lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
palm kernel oil	INACTIVE INGREDIENT	B0S90M0233	1
PPG-1 trideceth-6	INACTIVE INGREDIENT	1K7417JX6Q	1
tribehenin	INACTIVE INGREDIENT	8OC9U7TQZ0	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

Bain de Soleil Mega Tan SPF 4
Octinoxate and Octocrylene
WATER
BUTYLENE GLYCOL
CYCLOMETHICONE 5
MINERAL OIL
PPG-1 TRIDECETH-6
ISOHEXADECANE
TRIBEHENIN
CETYL PALMITATE
DISTEARYLDIMONIUM CHLORIDE
ALOE VERA LEAF
EUCALYPTUS GLOBULUS LEAF
APRICOT
CHAMOMILE
COCOA
PALM KERNEL OIL
LANOLIN
IODOPROPYNYL BUTYLCARBAMATE
DMDM HYDANTOIN
CETYL ALCOHOL
EDETATE DISODIUM
DIHYDROXYACETONE
OCTINOXATE
OCTOCRYLENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-7094	11523-7094-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
PPG-1 TRIDECETH-6	1K7417JX6Q	IACT
ISOHEXADECANE	918X1OUF1E	IACT
TRIBEHENIN	8OC9U7TQZ0	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT
DISTEARYLDIMONIUM CHLORIDE	OM9573ZX3X	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
EUCALYPTUS GLOBULUS LEAF	S546YLW6E6	IACT
APRICOT	269CJD5GZ9	IACT
CHAMOMILE	FGL3685T2X	IACT
COCOA	D9108TZ9KG	IACT
PALM KERNEL OIL	B0S90M0233	IACT
LANOLIN	7EV65EAW6H	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
CETYL ALCOHOL	936JST6JCN	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
DIHYDROXYACETONE	O10DDW6JOO	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 147 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
cyclomethicone 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
cetyl palmitate	CETYL PALMITATE	5ZA2S6B08X	CREAM / VAGINAL		165 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
cocoa	COCOA	D9108TZ9KG	SUSPENSION / ORAL	246.66 mg/5ml		Exact identifier — unii candidate
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
cetyl palmitate	CETYL PALMITATE	5ZA2S6B08X	SOLUTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
butylene glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
04db8d76-be3f-7134-e063-6294a90ad966			6c517222-35fe-4d93-8fc9-bd38ccda65fc	2023-09-08	Warnings	Exact identifier spl id: 04db8d76-be3f-7134-e063-6294a90ad966 spl set id: 6c517222-35fe-4d93-8fc9-bd38ccda65fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.