Hello Sunday The One For Your Lips Clear Lip Balm Spf 50

Hello Sunday The One For Your Lips Clear Lip Balm Spf 50
SPL v2
SPL
SPL Set ID 0c92dfc3-782d-e11f-e063-6394a90a2f8a
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (90 mg) Homosalate (73 mg)
Inactive Ingredients
Polyisobutylene (1300 Mw) Hyaluronate Sodium Rice Germ Silicon Dioxide Trihydroxystearin Silica Dimethyl Silylate Squalane Dicaprylyl Carbonate Butyloctyl Salicylate Octyldodecanol Shea Butter Tocopherol Glyceryl Monobehenate Synthetic Wax (1200 Mw) 1,2-hexanediol Propylene Carbonate Ethylhexyl Palmitate Levomenol Konjac Mannan Physalis Angulata Whole Caprylyl Glycol Benzyl Benzoate Polyglyceryl-3 Diisostearate Medium-chain Triglycerides Soybean Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

AVOBENZONE 3% HOMOSALATE 7.3% OCTISALATE 5% OCTOCRYLENE 9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% HOMOSALATE 7.3% OCTISALATE 5% OCTOCRYLENE 9%

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

Other Information
  • protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 7.3%

OCTISALATE 5%

OCTOCRYLENE 9%

Inactive Ingredients

POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.

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

Other Information
  • protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 7.3%

OCTISALATE 5%

OCTOCRYLENE 9%

Inactive Ingredients

POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.

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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