SKIN ACTIVE INTENSIVE DAY- octocrylene, avobenzone, oxybenzone, and ensulizole cream

Skin Active by

Drug Labeling and Warnings

Skin Active by is a Otc medication manufactured, distributed, or labeled by Cat Media Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octocrylene 5.0%
Avobenzone 2.0%	Sunscreen
Oxybenzone 1.0%
Ensulizole 1.0%

Use

helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove

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

Directions

• 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10am-2pm
• Wear long sleeved shirts, pants, hats and sunglasses

Inactive ingredients

Alkyl (C12-15) Benzoate, Carbomer Interpolymer Type A, Cetostearyl Alcohol, Edetate Sodium, Fragrance, Glyceryl Monostearate, Isopropyl Myristate, Methylparaben, Phenoxyethanol, Potassium Cetyl Phosphate, Propylparaben, Sodium Hydroxide, Water,

Other Information

Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

NORTH AMERICA
PharmaCare US
5030 Camino De La Siesta
San Diego, CA 92108

PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton

SKIN
DOCTORS™
COSMECEUTICALS

skinactive14™

intensive day cream

14 × problems solved

15 × cosmeceutical actives

complete solution for your
skin's most common problems

e 50ml 1.7 fl oz NET

DAY

BROAD SPECTRUM
SPF15
sun
protection

INGREDIENTS AND APPEARANCE

SKIN ACTIVE   INTENSIVE DAY
octocrylene, avobenzone, oxybenzone, and ensulizole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49203-710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	49.7 mg  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	19.9 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	9.9 mg  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	9.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Water (UNII: 059QF0KO0R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium hydroxide (UNII: 55X04QC32I)
Cetostearyl alcohol (UNII: 2DMT128M1S)
Isopropyl myristate (UNII: 0RE8K4LNJS)
Potassium cetyl phosphate (UNII: 03KCY6P7UT)
Carbomer homopolymer Type C (UNII: 4Q93RCW27E)
Edetate Sodium (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49203-710-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP
2	NDC: 49203-710-02	1 in 1 CARTON
2		50 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/01/2011

Labeler - Cat Media Pty Ltd (749710331)