AMBI EVEN AND CLEAR DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Ambi Even and Clear Daily Moisturizer by

Drug Labeling and Warnings

Ambi Even and Clear Daily Moisturizer by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Vee Pak, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (12%), Octisalate (5%), Octocrylene (1.7%), Oxybenzone (3%)

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.

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 generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months of age: Ask a doctor

Other Information

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

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Dimethicone, Glycine Soja (Soybean) Seed Extract, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glycerin, Ethylene/Acrylic Acid Copolymer, Phenoxyethanol, Phenyl Trimethicone, Silica, Panthenol, Arachidyl Alcohol, Aluminum Starch Octenylsuccinate, Cetearyl Glucoside, Methylparaben, Steareth-2, Polyacrylate-13, Behenyl Alcohol, Steareth-21, Polymethyl Methacrylate, Disodium EDTA, Arachidyl Glucoside, Polyisobutene, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Propylparaben, Tocopheryl Acetate, Ethylparaben, Benzalkonium Chloride, Polysorbate 20, PEG-16 Soy Sterol, Sodium Ascorbyl Phosphate, Butylene Glycol, Fragrance, Sodium Hydroxide, Glycine Soja (Soybean) Protein, Mica, Titanium Dioxide

Questions/Comments

1-800-321-4576

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Carton

AMBI®
SKINCARE

EVEN & CLEAR®

3 fl. oz. (88 mL)

INGREDIENTS AND APPEARANCE

AMBI EVEN AND CLEAR DAILY MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-5475
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	120 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	17 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Soybean (UNII: L7HT8F1ZOD)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Glycerin (UNII: PDC6A3C0OX)
Phenoxyethanol (UNII: HIE492ZZ3T)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Panthenol (UNII: WV9CM0O67Z)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Methylparaben (UNII: A2I8C7HI9T)
Steareth-2 (UNII: V56DFE46J5)
Docosanol (UNII: 9G1OE216XY)
Steareth-21 (UNII: 53J3F32P58)
Edetate Disodium (UNII: 7FLD91C86K)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Propylparaben (UNII: Z8IX2SC1OH)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylparaben (UNII: 14255EXE39)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
Sodium Hydroxide (UNII: 55X04QC32I)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-5475-03	1 in 1 CARTON
1		88 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/11/2013

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak, Inc.		360761134	MANUFACTURE(0187-5475)