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

SolMate

Prime Packaging, Inc.
Prime Packaging, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PRINCIPAL DISPLAY PANEL - 295 mL Can Label

PRINCIPAL DISPLAY PANEL - 295 mL Can Label


SOL

MATE

KID'S

CONTINUOUS SPRAY

SUNSCREEN

50

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

10 FL. OZ. / 295 mL

Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 4 %

Purpose

Purpose

Sunscreen

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.

  • keep away from face to avoid breathing it.
  • Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 1200F

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.

Flammable: Do not use near heat, flame or while smoking.

Directions

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in well-ventilated areas.
  • reapply:
    • after 80 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 skin aging. To decrease this risk, regularly use a sunscreen with 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

Fragrance (Parfum), Glycerin,  SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

  • protect this product from excesive heat and direct sun
  • may stain some fabrics

Questions or Comments? Biocycle Laboratories, Inc.

16363 NW 49th Avenue, Miami, FL 33014

SolMate

Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13630-0057
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 25.4 mg
HOMOSALATE Homosalate 84.7 mg
OCTISALATE OCTISALATE 42.4 mg
OCTOCRYLENE Octocrylene 23.3 mg
OXYBENZONE OXYBENZONE 33.9 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
ALCOHOL

Product Characteristics

Color
yellow

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13630-0057-5 295 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-04-23


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