PROACTIV CLEAR SKIN SPF 30- avobenzone, octisalate, and octocrylene lotion

Proactiv Clear Skin SPF 30 by

Drug Labeling and Warnings

Proactiv Clear Skin 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]

SPL UNCLASSIFIED SECTION

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 
• 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 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.
  • Children under 6 months; Ask a doctor.

Other Information

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

Inactive Ingredients

Water, Isopropyl Lauroyl Sarcosinate, Glycerin, Dimethicone, Diisopropyl Sebacate, Sucrose Tristearate, Polymethyl Methacrylate, Silica, Aluminum Starch Octenylsuccinate, Pentylene Glycol, Polysorbate 61, Sodium Stearoyl Glutamate, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Dimethiconol, Glycyrrhetinic Acid, Xanthan Gum, Potassium Sorbate, Disodium EDTA, Panthenol, Carbomer, Allantoin, Triethanolamine, Zinc Gluconate, Hydroxypalmitoyl Sphinganine

Questions?

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in Canada of foreign and domestic components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 45 ML Tube Box

proactiv®

CLEAR SKIN
SPF 30

Broad-spectrum
SPF30
sunscreen

1.5 FL OZ
45 ML

INGREDIENTS AND APPEARANCE

PROACTIV CLEAR SKIN SPF 30 
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-073
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: 11410-073-00	1 in 1 BOX	12/13/2021
1		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 Drug	M020	12/13/2021

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
G Production Inc.		251676961	manufacture(11410-073)