luminous defense spf 50

luminous defense spf 50
SPL v2
SPL
SPL Set ID 22e177b3-beea-212e-e063-6394a90a1452
Route
topical
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (120 mg)
Inactive Ingredients
silicon dioxide allantoin lecithin, sunflower sodium hydroxide polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate niacinamide methylpropanediol polyglyceryl-3 pentaricinoleate tocopherol water helianthus annuus flowering top polyglyceryl-2 dipolyhydroxystearate caprylyl glycol rice bran nylon-12 tetrasodium glutamate diacetate jojoba oil, randomized propanediol phenylpropanol rosemary alkyl (c12-15) benzoate medium-chain triglycerides tridecyl salicylate bakuchiol coco-caprylate sodium chloride levomenol stearalkonium hectorite polyglyceryl-3 diisostearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-01

Purpose

Sunscreen

Description

Zinc Oxide 12%


Medication Information

Warnings

For external use only

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

Directions
  • Shake well before use
  • Apply generously 15 minutes before sun exposure
  • Reapply:
  • after 40 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 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-sleeve 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, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

Description

Zinc Oxide 12%

Do Not Use

on damaged or broken skin

Product Label

Active Ingredient

Zinc Oxide 12%

Company Information

Manufactured For Levels 2 Skin, LLC | Atlanta, GA 30316 | Levels2Skin.com | [email protected]

Questions Or Comments?
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 product is swallowed, get medical help or contact Poison Control Center right away.


Structured Label Content

Warnings

For external use only

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

Directions
  • Shake well before use
  • Apply generously 15 minutes before sun exposure
  • Reapply:
  • after 40 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 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-sleeve 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, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

Do Not Use (Do not use)

on damaged or broken skin

Product Label

Active Ingredient

Zinc Oxide 12%

Company Information

Manufactured For Levels 2 Skin, LLC | Atlanta, GA 30316 | Levels2Skin.com | [email protected]

Questions Or Comments? (Questions or comments?)
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 product is swallowed, get medical help or contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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