Total Sun Protection description, usages, side effects, indications, overdosage, supplying and lots more!

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Total Sun Protection

Cosmed, Inc.
A.I.G. Technologies, Inc.

Clinicians Complex Total Sun Protection SPF 30+


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Octinoxate 7.5% w/w

Zinc Oxide 3.8% w/w

Octisalate 3.0% w/w

Oxybenzone 3.0% w/w

Purpose

Sunscreen

Total Sun Protection 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

Keep out of reach of children.

For external use only. Do not use on damaged or broken skin. Stop use and ask 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

• Apply liberally 15 minutes before sun exposure and as needed

• Reapply:

        • After 40 minutes of swimming or sweating

        • Immediately after towel drying

        • At least every 2 hours

        • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 10am to 2pm

          • Wear long sleeve shirts, pants, hats, and sun glasses

          • Children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments:

Call 770-965-1022

Inactive Ingredients

Water, PPG-3 Mryistyl Ether, Aloe Barbadensis Gel, Glycol Stearate, Cetyl Alcohol, Polyacrylamide, PVP/Hexadecene Copolymer, Camellia Oleisera Leaf Extract, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Propylene Glycol, C13-14 Isoparaffin, Decyl Glucoside, Silica, Cetyl Phosphate, Glyceryl Stearate, PEG 100 Stearate, Glycerrin, Diazolidinyl Urea, Triethoxycaprylylsilane, Methylparaben, Disodium EDTA, Propylparaben, Laureth-7

Total Sun Protection

Total Sun Protection

Octinoxate, Zinc Oxide, Octisalate, Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61352-003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
Zinc Oxide Zinc oxide 38 mg
OCTISALATE OCTISALATE 30 mg
OXYBENZONE OXYBENZONE 30 mg

Inactive Ingredients

Ingredient Name Strength
PPG-3 MYRISTYL ETHER
Aloe Vera Leaf
GLYCOL STEARATE
CETYL ALCOHOL
POLYACRYLAMIDE (10000 MW)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)
CAMELLIA OLEIFERA LEAF
CAMELLIA SINENSIS WHOLE
.ALPHA.-TOCOPHEROL ACETATE
propylene glycol
C13-14 ISOPARAFFIN
DECYL GLUCOSIDE
SILICON DIOXIDE
CETYL PHOSPHATE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
GLYCERIN
DIAZOLIDINYL UREA
TRIETHOXYCAPRYLYLSILANE
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
LAURETH-7

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61352-003-01 127.6 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-08-01


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