Unscented SPF 17 description, usages, side effects, indications, overdosage, supplying and lots more!

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Unscented SPF 17

CoValence, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:  Zinc Oxide 7%

OTC - PURPOSE SECTION

Purpose:  Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

(Part of Warnings section)

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

INDICATIONS & USAGE SECTION

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 SECTION

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 the product is sqallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures. Spending time in the sun increases 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 INGREDIENT SECTION

Inactive Ingredients:  Alcohol Denat., Aluminum Silicate, Aqua (Water), Astaxanthin, Beta-Glucan (D), Caprylic/Capric Triglyceride, Carbomer, Cetearyl Olivate, Cyclopentasiloxane, Elaeis Guineensis (Palm) Oil, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Magnesium Glyceryl Isostearate, Olea Europaea (Olive) Fruit Oil*, Polyhydroxystearic Acid, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Seed Oil*, Sodium Benzoate, Sorbitan Olivate, Squalane, Tetrahydrobisdemethoxydiferuloylmethane, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydeferuloylmethane, Tetrasodium EDTA, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha), Tocotrienols, Triticum Vulgare (Wheat) Germ Oil, Xanthan Gum

OTHER SAFETY INFORMATION

Other Information:

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

Unscented SPF 17

Unscented SPF 17

Zinc Oxide 7% CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66915-613
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide .07 g

Inactive Ingredients

Ingredient Name Strength
water
MEDIUM-CHAIN TRIGLYCERIDES
CETEARYL OLIVATE
GLYCERIN
CYCLOMETHICONE 5
SORBITAN OLIVATE
SQUALANE
WHEAT GERM OIL
olive oil
Jojoba Oil
ASTAXANTHIN
.Alpha.-Tocopherol, D-
.ALPHA.-TOCOPHEROL ACETATE
TETRAHYDRODIFERULOYLMETHANE
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE
SOYBEAN OIL
POPULUS TREMULOIDES BARK
TROPOLONE
tocotrienols
LONICERA JAPONICA FLOWER
Lonicera Caprifolium Flower
GLUCONOLACTONE
palm oil
GLYCERYL ISOSTEARATE
CAPRYLYL GLYCOL
magnesium aluminum silicate
POLYHYDROXYSTEARIC ACID (2300 MW)
1,2-HEXANEDIOL
ALCOHOL
XANTHAN GUM
CITRIC ACID MONOHYDRATE
phytic acid
POTASSIUM SORBATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66915-613-01 200000 in 1 DRUM
2 NDC:66915-613-02 270 in 1 BOTTLE, PLASTIC
3 NDC:66915-613-03 80 in 1 BOTTLE, PLASTIC
4 NDC:66915-613-04 30 in 1 JAR
5 NDC:66915-613-07 1 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-08-12


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