SPF 20 description, usages, side effects, indications, overdosage, supplying and lots more!

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SPF 20

CoValence, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient:

Zinc Oxide 15%

Purpose:

Sunscreen

Keep Out Of Reach Of Children:

(Warnings Section)

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

(Directions Section)

  • Children under 6 months; Ask a doctor.

Uses:

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

  • 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 for Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun screases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months; ask a doctor.

Inactive Ingredients:

Aqua (Water), Cyclopentasiloxane, Sucrose Stearate, PEG-10 Dimethicone, C12-15 Alkyl Benzoate, Galactoarabinan, Sodium Hyaluronate (L), Algae Extract, Tetrahexyldecyl Ascorbate, Carpylhydroxamic Acid, Ethylhexylglycerin, Methylpropanediol, Tocopherol (D-alpha), Glycine Soja (Soybean) Oil, Cyclopentasiloxane, Methicone, Hamamelis Virginiana (Witch Hazel) Water, Alcohol, Citric Acid, Phytic Acid, Potassium Sorbate, Caprylyl Glycol, Phenethyl Alchol

Other Information:

Protect this product from excessive heat and direct sun.

Principal Display Panel

SPF 20

SPF 20

Zinc Oxide 15% CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66915-608
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide .15 g

Inactive Ingredients

Ingredient Name Strength
water
CYCLOMETHICONE 5
SUCROSE STEARATE
PEG-10 DIMETHICONE (600 CST)
C12-15 ALKYL BENZOATE
GALACTOARABINAN
HYALURONATE SODIUM
TETRAHEXYLDECYL ASCORBATE
CAPRYLHYDROXAMIC ACID
ETHYLHEXYLGLYCERIN
methylpropanediol
Tocopherol
SOYBEAN OIL
METHICONE (20 CST)
WITCH HAZEL
ALCOHOL
CITRIC ACID ACETATE
phytic acid
POTASSIUM SORBATE
CAPRYLYL GLYCOL
PHENETHYL ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66915-608-01 200000 in 1 DRUM
2 NDC:66915-608-02 102 in 1 TUBE
3 NDC:66915-608-03 134 in 1 TUBE
4 NDC:66915-608-04 529 in 1 BOTTLE
5 NDC:66915-608-05 17 in 1 TUBE
6 NDC:66915-608-07 1 in 1 KIT

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-18


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