ESIKA PERFECT SUN- avobenzone, octisalate, octocrylene, and oxybenzone liquid

ESIKA by

Drug Labeling and Warnings

ESIKA by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation, Ltd., Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
AVOBENZONE (3.0%)	Sunscreen
OCTISALATE (5.0%)	Sunscreen
OCTOCRYLENE (10.0%)	Sunscreen
OXYBENZONE:6.0%	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.

• Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Children under 6 months of age: 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 the product in this container from excessive heat and direct sun.

Inactive ingredients

ALCOHOL DENAT., CYCLOPENTASILOXANE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, C12-15 ALKYL BENZOATE, DIMETHICONE, FRAGRANCE, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE.

SPL UNCLASSIFIED SECTION

P.R.: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 150 ml Bottle

SPF
30
BROAD
SPECTRUM

Perfect
sun

sunscreen body spray SPF 30
WATER RESISTANT
(40 MINUTES)

ēsika

150 ml e (5 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA   PERFECT SUN
avobenzone, octisalate, octocrylene, and oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.1 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
cyclomethicone 5 (UNII: 0THT5PCI0R)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
dimethicone (UNII: 92RU3N3Y1O)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
aloe vera leaf (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-153-01	150 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/24/2012

Labeler - Ventura Corporation, Ltd. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE