Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy

Hello Sunday The Mineral Lip One Nourishing Lip Tint Spf 45 Berry Balmy
SPL v2
SPL
SPL Set ID 26bcb9cd-bfb5-998c-e063-6394a90ab9d6
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (229.5 mg)
Inactive Ingredients
Helianthus Annuus (sunflower) Seed Wax Jojoba Oil, Randomized Sorbitan Olivate Silicon Dioxide Dehydroacetic Acid Hydrogenated Castor Oil Stearalkonium Hectorite Diisostearyl Malate Titanium Dioxide Polyglyceryl-4 Isostearate Isostearic Acid Pentaerythrityl Tetraisostearate Ci 45410 Polyhydroxystearic Acid (2300 Mw) Bis-diglyceryl Polyacyladipate-2 Polyglyceryl-3 Pentaricinoleate Acacia Decurrens Flower Wax Hyaluronic Acid Ferric Oxide Red Propylene Carbonate Castor Oil Tocopherol Butyloctyl Salicylate Candelilla Wax Lecithin, Sunflower Sorbitan Isostearate Polyglycerin-3 Caprylic/capric Triglyceride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-12

Description

ZINC OXIDE 22.95%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

ZINC OXIDE 22.95%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.
Warnings

For external use only

Directions
  • Apply generously to lips before sun exposure.
  • Reapply frequently
  • Do not swallow
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. 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

Product Packaging

Active Ingredients

ZINC OXIDE 22.95%

Inactive Ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, JOJOBA ESTERS, PENTAERYTHRITYL TETRAISOSTEARATE, DIISOSTEARYL MALATE, BUTYLOCTYL SALICYLATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN OLIVATE, MORINGA OIL/HYDROGENATED MORINGA OIL ESTERS, POLYHYDROXYSTEARIC ACID, SILICA, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, SORBITAN ISOSTEARATE, ACACIA DECURRENS FLOWER WAX, DEHYDROACETIC ACID, FLAVOR/AROMA, HYALURONIC ACID, HYDROGENATED CASTOR OIL, IRON OXIDES, POLYGLYCERIN-3, PROPYLENE CARBONATE, RED 28 LAKE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEARALKONIUM HECTORITE, TITANIUM DIOXIDE, TOCOPHEROL

Questions Or Comments?

1-888-426-0695

Monday-Friday, 9 a.m. - 5 p.m. EST

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 ageing caused by the sun.
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply generously to lips before sun exposure.
  • Reapply frequently
  • Do not swallow
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. 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

Product Packaging

Active Ingredients

ZINC OXIDE 22.95%

Inactive Ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, JOJOBA ESTERS, PENTAERYTHRITYL TETRAISOSTEARATE, DIISOSTEARYL MALATE, BUTYLOCTYL SALICYLATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYGLYCERYL-4 ISOSTEARATE, SORBITAN OLIVATE, MORINGA OIL/HYDROGENATED MORINGA OIL ESTERS, POLYHYDROXYSTEARIC ACID, SILICA, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, SORBITAN ISOSTEARATE, ACACIA DECURRENS FLOWER WAX, DEHYDROACETIC ACID, FLAVOR/AROMA, HYALURONIC ACID, HYDROGENATED CASTOR OIL, IRON OXIDES, POLYGLYCERIN-3, PROPYLENE CARBONATE, RED 28 LAKE, RICINUS COMMUNIS (CASTOR) SEED OIL, STEARALKONIUM HECTORITE, TITANIUM DIOXIDE, TOCOPHEROL

Questions Or Comments? (Questions or comments?)

1-888-426-0695

Monday-Friday, 9 a.m. - 5 p.m. EST

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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