stokoderm®

stokoderm®
SPL v2
SPL
SPL Set ID 3ddf81e6-de78-4f2f-814b-c75eadcddb39
Route
topical
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octocrylene (10 g) octisalate (5 g) homosalate
Inactive Ingredients
water butyloctyl salicylate xanthan gum sodium polyacrylate (2500000 mw) styrene/acrylamide copolymer (500000 mw) edetate disodium anhydrous vinylpyrrolidone/hexadecene copolymer dimethicone caprylyl trisiloxane ethylhexyl stearate butylated hydroxytoluene glyceryl stearate se trideceth-6 docosanol trimethylsiloxysilicate (m/q 0.8-1.0) polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) dimethyl capramide hydrated silica .alpha.-tocopherol acetate phenoxyethanol ethylhexylglycerin peg-100 stearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-02-01

Description

Drug Facts


Medication Information

Warnings

For external use only

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.
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

Description

Drug Facts

Questions?

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredients (w/w) Purpose
Avobenzone 3% Sunscreen
Homosalate 5% Sunscreen
Octisalate 3%, Octocrylene 10% Sunscreen
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


Structured Label Content

Warnings

For external use only

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.
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 (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients (w/w) Purpose
Avobenzone 3% Sunscreen
Homosalate 5% Sunscreen
Octisalate 3%, Octocrylene 10% Sunscreen
Principal Display Panel 100 Ml Tube Label (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


Advanced Ingredient Data


Raw Label Data

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