Sun X Spf 30 Thick New Formulation

Sun X Spf 30 Thick New Formulation
SPL v1
SPL
SPL Set ID 08fb4748-d22d-35af-e063-6394a90a0827
Route
TOPICAL
Published
Effective Date 2021-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Avobenzone (3 g) Homosalate (7.5 g) Octisalate
Inactive Ingredients
Alkyl (c12-15) Benzoate Carbomer Homopolymer, Unspecified Type Disodium Edta-copper Sodium Hydroxide Peg-6 Sorbitan Oleate Theobroma Cacao Whole Ethylhexylglycerin Polysorbate 20 Methylcellulose, Unspecified Propylene Glycol Propyl Ether Medium Density Polyethylene Water Aloe Vera Leaf .alpha.-tocopherol Acetate Phenoxyethanol Acrylates Crosspolymer-6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-07 Until 2022-11-21

Description

Avobenzone 3% Homosalate 7.5% Octisalate 5% Octocylene 5%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 3% Homosalate 7.5% Octisalate 5% Octocylene 5%

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 sweatingchildren under 6 months of age: Ask a doctor
    • 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 of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • children under 6 months: Ask a doctor
Do Not Use

on damaged or broken skin

Other Information
  • Protect this product from excessive heat or direct sun.
Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan, oleate, theobroma cacao (cocoa) seed butter, tocopherol acetate, water

Principal Display Panel

Questions and Comments?

Call: 1-877-684-5774

When Using This Product

keep out of the eyes. Rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs

Keep Out of the Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


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

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweatingchildren under 6 months of age: Ask a doctor
    • 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 of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • children under 6 months: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • Protect this product from excessive heat or direct sun.
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Inactive Ingredients (Inactive ingredients)

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan, oleate, theobroma cacao (cocoa) seed butter, tocopherol acetate, water

Principal Display Panel

Questions and Comments? (Questions and comments?)

Call: 1-877-684-5774

When Using This Product (When using this product)

keep out of the eyes. Rinse with water to remove

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

if rash occurs

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

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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