Sun X Spf 30 Thick Multi-pack New Formulation

Sun X Spf 30 Thick Multi-pack New Formulation
SPL v3
SPL
SPL Set ID f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f
Route
TOPICAL
Published
Effective Date 2023-01-08
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 2023-01-08

Description

Avobenzone 3% Homosalate 7.5% Octisalate 5% Octocrylene 5%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 3% Homosalate 7.5% Octisalate 5% Octocrylene 5%

Uses
  • helps prevent sunburn.
  • higher SPF gives more sunburn protection.
  • retains SPF after 80 minutes of activity in the water or sweating.
  • provides high protection against sunburn.
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
    • after towel drying, swimming, or
    • at least every 2 hours
    • children under 6 months of age: ask a doctor.
Do Not Use

on damaged or broken skin

65753 109 24

Kit Contents

1-Towelette

Other Information
  • Protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 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, tocopheryl acetate, water

65753 109 22 23 31 26

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 or irritation develops and lasts
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.
  • higher SPF gives more sunburn protection.
  • retains SPF after 80 minutes of activity in the water or sweating.
  • provides high protection against sunburn.
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 sweating
    • after towel drying, swimming, or
    • at least every 2 hours
    • children under 6 months of age: ask a doctor.
Do Not Use (Do not use)

on damaged or broken skin

65753 109 24 (65753-109-24)

Kit Contents

1-Towelette

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 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, tocopheryl acetate, water

65753 109 22 23 31 26 (65753-109-22-23-31-26)

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 If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts
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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