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

Proactiv MD Daily Oil Control SPF 30 by

Drug Labeling and Warnings

Proactiv MD Daily Oil Control SPF 30 by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, G Production Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-957
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	7 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-957-44	1 in 1 BOX	05/22/2017
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-957-17	1 in 1 BOX	05/22/2017
2		45 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/22/2017

Labeler - The Proactiv Company, LLC (080216357)