Bain de Soleil Orange Creme description, usages, side effects, indications, overdosage, supplying and lots more!

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Bain de Soleil Orange Creme

Schering-Plough HealthCare Products, Inc.

BAIN de SOLEIL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Octinoxate 3.5%, Oxybenzone 1.5%

Purpose

Sunscreen

Bain de Soleil Orange Creme 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

Bain de Soleil Orange Creme 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)

Bain de Soleil Orange Creme

Bain de Soleil Orange Creme

Octinoxate and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7305
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 35 mg
OXYBENZONE OXYBENZONE 15 mg

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)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7305-1 99 in 1 TUBE
2 NDC:11523-7305-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 1999-05-21


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