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Name:Bain De Soleil Orange Creme Spf 4
Manufacturer:Schering-plough Healthcare Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BAIN de SOLEIL®

BAIN DE SOLEIL ORANGE CREME  SPF 4 - octinoxate and oxybenzone lotion 
Schering-Plough HealthCare Products, Inc.

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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BAIN de SOLEIL®

Drug Facts

Active ingredients

Octinoxate 3.5%, Oxybenzone 1.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external use only

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

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions

  • adults and children 6 months of age and older: apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
  • children under 6 months of age: ask a doctor

Other information

  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, PEG-8, Aluminum Starch Octenylsuccinate, Isopropyl Laurate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Diazolidinyl Urea, Propylene Glycol, Methylparaben, Propylparaben, Disodium EDTA, Fragrance, Tocopherol (Vitamin E), Triethanolamine,FD&C Yellow No. 6, FD&C Red No. 40.

PRINCIPAL DISPLAY PANEL

BAIN
de
SOLEIL®

ULTRA LIGHT

ORANGE CRÈME

4
spf

sunscreen

elegant crème
oil-free & ultra light
signature fragrance

NET WT 3.5 OZ (99g)

Principal Display Panel

BAIN DE SOLEIL ORANGE CREME   SPF 4
octinoxate and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7305
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 35 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 15 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
DiazolidinylUrea  
Propylene Glycol  
Methylparaben  
Propylparaben  
Edetate Disodium  
Alpha-Tocopherol  
Trolamine  
FD&C Yellow No. 6  
FD&C Red No. 40  
Product Characteristics
Color ORANGE (peach colored) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11523-7305-2 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (11523-7305-1)
1 NDC:11523-7305-1 99 g in 1 TUBE This package is contained within the CARTON (11523-7305-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/21/1999

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 02/2010 Schering-Plough HealthCare Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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