STOKODERM SUNSCREEN PURE- avobenzone, octocrylene, octisalate, and homosalate cream

Stokoderm Sunscreen PURE by

Drug Labeling and Warnings

Stokoderm Sunscreen PURE by is a Otc medication manufactured, distributed, or labeled by SC Johnson Professional USA, Inc., Formulated Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (w/w)	Purpose
Avobenzone 3%	Sunscreen
Homosalate 5%	Sunscreen
Octisalate 3%, Octocrylene 10%	Sunscreen

Uses

• SPF 30
• 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

• For sunscreen use:
  • apply generously 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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

Inactive ingredients

Water, Butyloctyl Salicylate, Hydrated Silica, VP/Hexadecene Copolymer, Styrene/Acrylates Copolymer, Dimethicone, Polyester-8, Phenoxyethanol, Caprylyl Methicone, Ethylhexyl Stearate, Trideceth-6, Glyceryl Stearate, PEG-100 Stearate, Sodium Polyacrylate, Behenyl Alcohol, Dimethyl Capramide, Ethylhexylglycerin, Trimethylsiloxysilicate, Xanthan Gum, Tocopheryl Acetate, Butylated Hydroxytoluene, Disodium EDTA

Questions?

Call toll free US: 1-800-248-7190

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

EXP JA-2020
LOT XXXX

SCJ PROFESSIONAL
A Family Company™

NDC: 11084-032-10

Stokoderm®
SUNSCREEN PURE

SUNSCREEN CREAM
Broad Spectrum SPF30 UVA/UVB Protection
Water Resistant (80 Minutes)

100mL
(3.38 fl oz)

deb
SKIN CARE

INGREDIENTS AND APPEARANCE

STOKODERM SUNSCREEN PURE 
avobenzone, octocrylene, octisalate, and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
DOCOSANOL (UNII: 9G1OE216XY)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-100 STEARATE (UNII: YD01N1999R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-032-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2021
2	NDC: 11084-032-10	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2021

Labeler - SC Johnson Professional USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions		143266687	MANUFACTURE(11084-032)