Naturium Phyto-glow Lip Balm Spf 45

Naturium Phyto-glow Lip Balm Spf 45
SPL v1
SPL
SPL Set ID 3808613f-88d6-6c1a-e063-6294a90a5bb2
Route
TOPICAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Octisalate
Inactive Ingredients
Cinnamal Red 6 Ricinus Communis (castor) Seed Oil Yellow 5 Polyglyceryl-2 Diisostearate Siraitia Grosvenorii Fruit Citric Acid Microcrystalline Wax Bht Limonene, (+)- Methyl Salicylate Tocopherol C12-15 Alkyl Benzoate Theobroma Grandiflorum Seed Butter Phytosteryl/isostearyl/cetyl/stearyl/behenyl Dimer Dilinoleate Eugenol Vanillin Polybutene (1400 Mw) Carvone Mica Hydrogenated Polyisobutene (450 Mw) Synthetic Wax (1200 Mw) Ethylhexyl Methoxycrylene Butyrospermum Parkii (shea) Butter Squalane Flavor Spice Mint N&a110589 Menthol Diisostearyl Malate Blue 1 Lake Red 7 Isopropyl Titanium Triisostearate Titanium Dioxide Ferrosoferric Oxide Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09

Description

Avobenzone 3% Homosalate 3% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 3% Octisalate 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.
Inactive

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Aroma/Flavor, Polyglyceryl-2 Diisostearate, Butyrospermum Parkii (Shea) Butter, Cera Microcristallina/Microcrystalline Wax/Cire Microcristalline, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Synthetic Wax, Mica, Squalane, Theobroma Grandiflorum Seed Butter, Siraitia Grosvenorii Fruit Extract, Tocopherol, Citric Acid, BHT, Carvone, Cinnamal, Eugenol, Limonene, Menthol, Methyl Salicylate, Vanillin.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in 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.
Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions?

1-888-315-9814

Packaging Label

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 3%

Octisalate 5%

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 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

Inactive

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Aroma/Flavor, Polyglyceryl-2 Diisostearate, Butyrospermum Parkii (Shea) Butter, Cera Microcristallina/Microcrystalline Wax/Cire Microcristalline, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Synthetic Wax, Mica, Squalane, Theobroma Grandiflorum Seed Butter, Siraitia Grosvenorii Fruit Extract, Tocopherol, Citric Acid, BHT, Carvone, Cinnamal, Eugenol, Limonene, Menthol, Methyl Salicylate, Vanillin.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in 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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

1-888-315-9814

Packaging Label

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 3%

Octisalate 5%

When Using This Product: (When using this product:)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If: (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 right away.

Advanced Ingredient Data


Raw Label Data

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