Bain de Soleil Orange Gelee ingredients

  • NDC Code(s): 11523-7189-1
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 14, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
  • Active ingredient
  • Purpose
  • Use
  • 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?
  • SPL UNCLASSIFIED SECTION

    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)

    Bain de Soleil Orange Gelee ingredients

View Labeling Archives for this drug

BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel

Number of versions: 5

Published Date (What is this?)VersionFiles
Oct 17, 2022 5 (current) download
Jun 9, 2020 4 download
Sep 9, 2019 3 download
Sep 28, 2016 2 download
Aug 20, 2014 1 download

RxNorm

BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel

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NDC Codes

BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel 
Bayer HealthCare LLC

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.

----------

Active ingredient

Octinoxate 2.5%

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

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)

Bain de Soleil Orange Gelee ingredients

Why did they discontinue Bain de Soleil?

According to a statement from Bayer, it “discontinued the production and sale of Bain de Soleil products due to limited consumer interest.” The company, which sold the Coppertone brand to Beiersdorf last year, added: “Given the fondness for the product, we can understand the disappointment.”

What else smells like Bain de Soleil?

What's a Good Dupe for Discontinued Bain de Soleil Orange Gelée?.
Vacation Classic Lotion SPF 30 Sunscreen. $18. ... .
Australian Gold Spray Gel Sunscreen with Instant Bronzer. $13. ... .
Michael Kors Signature Eau de Parfum. $48..