AMBI ESSENTIALS DAILY MOISTURIZER  SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene and oxybenzone lotion 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredients

Avobenzone (3%), 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, Diethylhexyl 2,6-Naphthalate, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Sodium Polyacrylate, Silica, PCA Dimethicone, Cetearyl Alcohol, Phenoxyethanol, Methyl Methacrylate Crosspolymer, Behenyl Alcohol, Aluminum Starch Octenylsuccinate, Steareth-2, Betaine, Fragrance, Arachidyl Glucoside, Methylparaben, Steareth-21, Disodium EDTA, Hydroxypropyl Methylcellulose, Cetearyl Glucoside, Sodium PCA, Propylparaben, Benzalkonium Chloride , Sorbitol, Ethylparaben, Boron Nitride, Serine, Iodopropynyl Butylcarbamate, Glycine, Glutamic Acid, Alanine, Arginine, Lysine, Threonine, Proline

Questions?

888-TRY-AMBI; Outside US, dial collect 215-273-8755 or visit www.ambiflawlessskin.com

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

AMBI®

ESSENTIALS
Daily Moisturizer
with
Sunscreen

BROAD SPECTRUM
SPF 15

Deeply nourishes without
heavy ingredients

Light, oil-free formula

Dermatologist tested

2 FL. OZ. (59mL)

Principal Display Panel - 59 mL Bottle Label
AMBI ESSENTIALS DAILY MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-0530
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30 mg  in 1 mL
Octisalate (Octisalate) Octisalate50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene17 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alkyl (C12-15) Benzoate 
Dimethicone 
Diethylhexyl 2,6-Naphthalate 
Glycerin 
Arachidyl Alcohol 
Phenyl Trimethicone 
Silicon Dioxide 
Cetostearyl Alcohol 
Phenoxyethanol 
Docosanol 
Aluminum Starch Octenylsuccinate 
Steareth-2 
Betaine 
Arachidyl Glucoside 
Methylparaben 
Steareth-21 
Edetate Disodium 
Cetearyl Glucoside 
Sodium Pyrrolidone Carboxylate 
Propylparaben 
Benzalkonium Chloride 
Sorbitol 
Ethylparaben 
Boron Nitride 
Serine 
Iodopropynyl Butylcarbamate 
Glycine 
Glutamic Acid 
Alanine 
Arginine 
Lysine 
Threonine 
Proline 
Packaging
#Item CodePackage Description
1NDC:58232-0530-259 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/16/201207/01/2013
Labeler - Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 03/2013
 
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.