OP Dark Formula Xtreme Tanning 4 description, usages, side effects, indications, overdosage, supplying and lots more!

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OP Dark Formula Xtreme Tanning 4

Sun & Skin Care Research, LLC

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients


Purpose

Sunscreen

OP Dark Formula Xtreme Tanning 4 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 Formula Xtreme Tanning 4

OP Dark Formula Xtreme Tanning 4

octinoxate, octisalate LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62802-600
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
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CARBOMER HOMOPOLYMER TYPE C
CARAMEL
CANOLA OIL
olive oil
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL ACETATE
SUNFLOWER OIL
BUTYLPARABEN
EDETATE DISODIUM
ETHYLPARABEN
GLYCERIN
HYPROMELLOSE 2910 (4000 MPA.S)
isobutylparaben
METHYLPARABEN
PHENOXYETHANOL
POLYISOBUTYLENE (2300 MW)
propylene glycol
PROPYLPARABEN
SORBITAN MONOOLEATE
TROLAMINE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62802-600-08 251 in 1 BOTTLE

Marketing Information

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


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