Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15 description, usages, side effects, indications, overdosage, supplying and lots more!

Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15

Elizabeth Arden, 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
BC1169

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

This multi-benefit moisturizer for dry skin provides intense hydration. Leaves skin feeling soft and smooth.

INDICATIONS AND USAGE

To Use: Smooth onto cleansed face and throat.

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 increases your risk of measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection hats, and sunglasses.

Children under 6 months ask a doctor.

WARNINGS

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.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.5%, Avobenzone 3.0%, Oxybenzone 3.0%.

INACTIVE INGREDIENT

Inactive Ingredients: Water/Aqua/Eau, Butylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Cetearyl Glucoside, Pentylene Glycol, Butyl Stearate, Tridecyl Salicylate, Cetyl Ricinoleate, Cyclopentasiloxane, Narcissus Tazetta Bulb Extrat, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Tocopherol, Tocopheryl Acetate, Caprylyl Glycol, Cetearyl Dimethicone Crosspolymer, Ethylhexyl Palmitate, Glyceryl Stearate, Sodium PCA, Trehalose, Urea, Hyrdolyzed Soy Protein, Lecithin, Phospholipids, Polyphophorylcholine Glycol Acrylate, Ammonium Acryloyldimethylaurate/VP Coplymer, PEG-100 Stearate, PEG-8 Laurate, PEG-60 Hydrogenated Castor Oil, Sodium Dodecylbenzenesulfonate, Polyquaternium-51, Styrene/Acrylates Copolymer, Hexylene Glycol, Isododecane, PEG-8, Xanthan Gum, Nylon-12, BHT, Disodium EDTA, Mica, Tin Oxide, Silica Dimethyl Silylate, Parfum/Fragrance, Benzyl Salicylate, Butylphenyl Methylpropional, Citonellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limnene, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Chlorphenesin, Titanium Dioxide (CI 77891).

DOSAGE AND ADMINISTRATION

Smooth on to face and throat.

OTC - KEEP OUT OF REACH OF CHILDREN

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

OTC - PURPOSE

Provides SPF 15 Sun Protection.

WHEN USING

Keep out of eyes.

Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15

OCTINOXATE, AVOBENZONE, and OXYBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67938-1169
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.75 g
AVOBENZONE AVOBENZONE 1.5 g
OXYBENZONE OXYBENZONE 1.5 g

Inactive Ingredients

Ingredient Name Strength
water
BUTYLENE GLYCOL
GLYCERIN
ISONONYL ISONONANOATE
DIMETHICONE
CETEARYL GLUCOSIDE
PENTYLENE GLYCOL
BUTYL STEARATE
TRIDECYL SALICYLATE
cetyl ricinoleate
CYCLOMETHICONE 5
NARCISSUS TAZETTA BULB
TRIFOLIUM PRATENSE FLOWER
HYALURONATE SODIUM
Tocopherol
.ALPHA.-TOCOPHEROL ACETATE
CAPRYLYL GLYCOL
ETHYLHEXYL PALMITATE
GLYCERYL MONOSTEARATE
SODIUM PYRROLIDONE CARBOXYLATE
TREHALOSE
UREA
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
PEG-100 STEARATE
PEG-8 LAURATE
SODIUM DODECYLBENZENESULFONATE
Hexylene Glycol
ISODODECANE
polyethylene glycol 400
XANTHAN GUM
NYLON-12
BUTYLATED HYDROXYTOLUENE
EDETATE DISODIUM
MICA
STANNIC OXIDE
SILICA DIMETHYL SILYLATE
BENZYL SALICYLATE
BUTYLPHENYL METHYLPROPIONAL
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE
BENZOIC ACID
BUTYLPARABEN
isobutylparaben
METHYLPARABEN
PHENOXYETHANOL
POTASSIUM SORBATE
PROPYLPARABEN
sorbic acid
CHLORPHENESIN
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67938-1169-2 50 in 1 JAR
2 NDC:67938-1169-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-11-15


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