Daily Deflector Waterlight description, usages, side effects, indications, overdosage, supplying and lots more!

Daily Deflector Waterlight

KATE SOMERVILLE SKINCARE LLC

  • 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

ACTIVE INGREDIENTS

TITANIUM DIOXIDE- 8.3%

ZINC OXIDE- 12.6%

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 WARM WATER TO REMOVE.

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.

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
  • 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 VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PST.

INACTIVE INGREDIENTS

WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, COCO-CAPRYLATE/CAPRATE, GLYCERIN, CAPRYLYL METHICONE, DICAPRYLYL ETHER, NYLON-6/12, DICAPRYLYL CARBONATE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, COCONUT ALKANES, METHYLCELLULOSE, STEARIC ACID, POLYHYDROXYSTEARIC ACID, SODIUM HYALURONATE, TOCOPHERYL ACETATE, ADENOSINE, LENTINUS EDODES EXTRACT, TREHALOSE, TRACETIN, TOCOPHEROL, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, UREA, SODIUM PCA, FRAGRANCE (PARFUM), ETHYLHEXYLGLYCERIN, POLYSORBGATE 20, POLYQUATERNIUM-51, CARBOMER, PENTYLENE GLYCOL, SODIUM LACTATE, DISODIUM EDTA, BENZOIC ACID, POTASSIUM SORBATE, PHENOXYETHANOL, ALUMINA

Daily Deflector Waterlight

TITANIUM DIOXIDE, ZINC OXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43479-201
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 8.3 g
Zinc Oxide Zinc oxide 12.6 g

Inactive Ingredients

Ingredient Name Strength
water
ISODODECANE
DIMETHICONE
BUTYLOCTYL SALICYLATE
C12-15 ALKYL BENZOATE
COCO-CAPRYLATE/CAPRATE
GLYCERIN
CAPRYLYL TRISILOXANE
DICAPRYLYL ETHER
NYLON-12
DICAPRYLYL CARBONATE
BUTYLENE GLYCOL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
COCONUT ALKANES
METHYLCELLULOSE (100 CPS)
STEARIC ACID
POLYHYDROXYSTEARIC ACID (2300 MW)
HYALURONATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
ADENOSINE
Lentinula Edodes Mycelium
TREHALOSE
triacetin
Tocopherol
PALMITOYL OLIGOPEPTIDE
PALMITOYL TETRAPEPTIDE-7
UREA
SODIUM PYRROLIDONE CARBOXYLATE
ETHYLHEXYLGLYCERIN
POLYSORBATE 20
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)
carbomer 940
PENTYLENE GLYCOL
sodium lactate
EDETATE DISODIUM
BENZOIC ACID
POTASSIUM SORBATE
PHENOXYETHANOL
ALUMINUM OXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43479-201-12 50 in 1 BOTTLE, PUMP
2 NDC:43479-201-52 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-06-22


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