Signature Spf 50 Clear Face Stick

Signature Spf 50 Clear Face Stick
SPL v2
SPL
SPL Set ID 477130d0-dbdb-4247-a39a-2c34dae4f934
Route
TOPICAL
Published
Effective Date 2020-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octocrylene (50 mg) Octisalate (42.3 mg) Titanium Dioxide (70 mg) Zinc Cation
Inactive Ingredients
Ethylhexyl Palmitate Ceresin Paraffin Yellow Wax Butyloctyl Salicylate Stearyl Alcohol Polyoxyl 20 Cetostearyl Ether Dimethicone Adipic Acid/diglycol Crosspolymer (20000 Mpa.s) .alpha.-tocopherol Acetate Vinylpyrrolidone/hexadecene Copolymer Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-01-01

Description

Homosalate 10%, Octocrylene 10%, Octisalate 5%, Titanium Dioxide4.23%, Zinc Oxide 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10%, Octocrylene 10%, Octisalate 5%, Titanium Dioxide4.23%, Zinc Oxide 7%

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: After 80 minutes of swimming or sweating 
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor

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
Do Not Use

on damaged or broken skin.

Questions?

1 (877) 978-6286

Other Information

Protect this product from excessive heat and direct sun. Keep this outer card for complete labeling information.

Package Labeling:

Active Ingredients

Homosalate 10%, Octocrylene 10%, Octisalate 5%, Titanium Dioxide4.23%, Zinc Oxide 7%

Inactive Ingredients

octyl palmitate, ozokerite, paraffin, beeswax, butyloctyl salicylate, stearyl alcohol, ceteareth-20, dimethicone, adipic acid/diglycol crosspolymer, tocopheryl acetate, VP/hexadecene copolymer, triethoxycaprylylsilane

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 immediately.


Structured Label Content

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
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: After 80 minutes of swimming or sweating 
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 6 months of age: Ask a doctor

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
Do Not Use (Do not use)

on damaged or broken skin.

Questions?

1 (877) 978-6286

Other Information (Other information)

Protect this product from excessive heat and direct sun. Keep this outer card for complete labeling information.

Package Labeling:

Active Ingredients (Active ingredients)

Homosalate 10%, Octocrylene 10%, Octisalate 5%, Titanium Dioxide4.23%, Zinc Oxide 7%

Inactive Ingredients (Inactive ingredients)

octyl palmitate, ozokerite, paraffin, beeswax, butyloctyl salicylate, stearyl alcohol, ceteareth-20, dimethicone, adipic acid/diglycol crosspolymer, tocopheryl acetate, VP/hexadecene copolymer, triethoxycaprylylsilane

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor  (Stop use and ask a doctor )

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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