Natural SPF 28 description, usages, side effects, indications, overdosage, supplying and lots more!

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Natural SPF 28

CoValence, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient(s):

11.6% Zinc Oxide, 0.67% Titanium Dioxide

Purpose:

Sunscreen

Warnings: (Keep Out Of Reach Of Children)

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

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 a rash occurs.

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 Ingredients:

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Ceteryl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-Beta), Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Hamamelis Virginiana (Witch Hazel) Water, Isononyl Isononanoate, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polyglyceryl-6 Polyricinoleate, Polysorbate 60, Potassium Sorbate, Simethicone, Sodium Benzoate, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine, Xanthan Gum

Other Information:

Protect this product from excessive heat and direct sun.

PDP

Natural SPF 28

Natural SPF 28

Zinc Oxide 11.6%, Titanium Dioxide 0.67% CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66915-604
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide .116 g
titanium dioxide .0067 g

Inactive Ingredients

Ingredient Name Strength
water
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
COCO-CAPRYLATE/CAPRATE
POLYSORBATE 60
GLYCERIN
SQUALANE
POLYGLYCERYL-6 DIOLEATE
ISONONYL ISONONANOATE
magnesium aluminum silicate
XANTHAN GUM
GLYCERYL ISOSTEARATE
POLYHYDROXYSTEARIC ACID (2300 MW)
ALUMINUM OXIDE
.ALPHA.-TOCOPHEROL ACETATE, D-
SOYBEAN OIL
Aloe Vera Leaf
DIMETHICONE
ALLANTOIN
POTASSIUM SORBATE
TRISODIUM ETHYLENEDIAMINE DISUCCINATE
CITRIC ACID MONOHYDRATE
POPULUS TREMULOIDES BARK
DICAPRYLYL ETHER
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
GLUCONOLACTONE
Lonicera Caprifolium Flower
LONICERA JAPONICA FLOWER
TROPOLONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66915-604-02 200000 in 1 DRUM
2 NDC:66915-604-07 100 in 1 BOTTLE
3 NDC:66915-604-08 70 in 1 TUBE
4 NDC:66915-604-12 120 in 1 TUBE
5 NDC:66915-604-14 30 in 1 BOTTLE
6 NDC:66915-604-16 65 in 1 JAR
7 NDC:66915-604-17 135 in 1 JAR
8 NDC:66915-604-20 70 in 1 TUBE
9 NDC:66915-604-21 30 in 1 BOTTLE
10 NDC:66915-604-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-12-02


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