PROACTIV MD DAILY OIL CONTROL SPF 30- avobenzone, octisalate, and octocrylene lotion 
Alchemee, LLC

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.

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Proactiv MD® Daily Oil Control SPF 30

Drug Facts

Active Ingredient

Avobenzone 3%,
Octisalate 5%,
Octocrylene 7%

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 product is 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 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 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sun glasses.

Inactive Ingredients

water, isopropyl lauroyl sarcosinate, glycerin, dimethicone, diisopropyl sebacate, polymethyl methacrylate, aluminum starch octenylsuccinate, sucrose tristearate, silica, pentylene glycol, polysorbate 61, dimethiconol, sodium stearoyl glutamate, phenoxyethanol, caprylyl glycol, tocopheryl acetate, glycyrrhetinic acid, panthenol, triethanolamine, allantoin, carbomer, potassium sorbate, zinc gluconate, xanthan gum, disodium EDTA, hydroxypalmitoyl sphinganine

Other Information

  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.

Questions?

1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 45 ML Tube Box

proactiv MD®

DAILY OIL CONTROL
SPF 30

Broad Spectrum
Sunscreen

For Acne Prone Skin

Dermatologist Developed
and Tested

1.5 FL OZ
45 ML

Principal Display Panel - 45 ML Tube Box
PROACTIV MD DAILY OIL CONTROL SPF 30 
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-957
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene7 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
Diisopropyl Sebacate (UNII: J8T3X564IH)  
Poly(Methyl Methacrylate; 450000 mw) (UNII: Z47NNT4J11)  
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
Sucrose Tristearate (UNII: 71I93STU5M)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Pentylene Glycol (UNII: 50C1307PZG)  
Polysorbate 61 (UNII: X9E1MY2JQG)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Enoxolone (UNII: P540XA09DR)  
Panthenol (UNII: WV9CM0O67Z)  
Trolamine (UNII: 9O3K93S3TK)  
Allantoin (UNII: 344S277G0Z)  
Carboxypolymethylene (UNII: 0A5MM307FC)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
Xanthan Gum (UNII: TTV12P4NEE)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
Hydroxypalmitoyl Sphinganine (UNII: NR33W2353T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-957-441 in 1 BOX05/22/201708/25/2023
115 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-957-171 in 1 BOX05/22/201708/25/2023
245 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/22/201708/25/2023
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc251676961manufacture(11410-957)

Revised: 11/2022
 
Alchemee, LLC