Bain de Soleil ® Orange Gelée ® SPF 4

Manufacturer: Bayer HealthCare LLC
Effective date: 2022-10-14
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:51:34

Label at a glance#

ProductBain de Soleil Orange Gelee SPF 4

Active ingredientOCTINOXATE

Label structure11 sections

Dosage and administration

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

Storage and handling

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

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 2.5%

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

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

866-288-3330

SPL UNCLASSIFIED SECTION

Distributed by

Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 88 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

4

BAIN de

SOLEIL ^®

SUNSCREEN

ORANGE GELÉE ^®

Classic Formula

Luxurious Emollients

NET WT 3.12 OZ (88g)

Carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11523-7189-1	2023-09-08	C162847	48780-1	0191ceaa-6205-198a-e063-dbdaa90aec3e	Bain de Soleil ® Orange Gelée ® SPF 4
11523-7189-1	2023-07-28	C162847	48780-1	0191ceaa-6205-198a-e063-dbdaa90aec3e	Bain de Soleil ® Orange Gelée ® SPF 4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
.Alpha.-Tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	1
D&C Red No. 17	INACTIVE INGREDIENT	ND733RX3JN	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Bain de Soleil Orange Gelee SPF 4
Octinoxate
MINERAL OIL
PETROLATUM
PARAFFIN
ISOPROPYL MYRISTATE
PROPYLPARABEN
.ALPHA.-TOCOPHEROL
D&C YELLOW NO. 10
ALUMINUM OXIDE
D&C RED NO. 17

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-7189	11523-7189-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
PARAFFIN	I9O0E3H2ZE	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
D&C RED NO. 17	ND733RX3JN	IACT
OCTINOXATE	4Y5P7MUD51	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 4 · 188 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / BUCCAL		24 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
Aluminum Oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SYSTEM / TOPICAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUPPOSITORY / RECTAL	0.11 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 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-be3e-7134-e063-6294a90ad966			7222f6f9-689e-4e00-91f5-4db159348dfd	2023-09-08	Warnings	Exact identifier spl set id: 7222f6f9-689e-4e00-91f5-4db159348dfd

Reported adverse events (FAERS/openFDA)#

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