OP Dark Tanning Xtreme Oil Amplifier SPF4 description, usages, side effects, indications, overdosage, supplying and lots more!

OP Dark Tanning Xtreme Oil Amplifier SPF4

Sun & Skin Care Research, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients


Purpose

Sunscreen

Uses

  • 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 prevent sunburn, not skin cancer or early skin aging.

For external use only.  Do not use on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.

Directions

  • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
  • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
  • children under 6 months:  Ask a doctor

Other Information

  • protect this product from excessive heat and direct sun
  • for use on skin only
  • avoid contact with fabric

OP Dark Tanning Xtreme Oil Amplifier SPF4

octinoxate, octisalate SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62802-010
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3 mL
OCTISALATE OCTISALATE 2 mL

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ALKYL (C12-15) BENZOATE
COCONUT OIL
CARROT
ORANGE OIL
olive oil
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL ACETATE
SUNFLOWER OIL
laureth-4
polysorbate 80
ALMOND OIL
CARROT SEED OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62802-010-85 251 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-01


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