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.
Updated October 14, 2022 If you are a consumer or patient please visit this version. 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. Drug Label Information
Skin Cancer/Skin Aging Alert
- 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
- 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
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
SPF
4
BAIN de
SOLEIL ®
SUNSCREEN
ORANGE GELÉE ®
Classic Formula
Luxurious Emollients
NET WT 3.12 OZ (88g)
View Labeling Archives for this drug
BAIN DE SOLEIL ORANGE GELEE SPF 4- octinoxate gel
Number of versions: 5
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
Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.
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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.
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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)