HELLO SUNDAY THE ONE FOR YOUR LIPS CLEAR LIP BALM SPF 50- avobenzone, homosalate, octisalate, octocrylene stick

Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 by

Drug Labeling and Warnings

Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 by is a Otc medication manufactured, distributed, or labeled by Kao USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

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

Do not use

on damaged or broken skin

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.

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

Other Information

• protect the product in this container from excessive heat and direct sun.

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

Product Packaging

INGREDIENTS AND APPEARANCE

HELLO SUNDAY THE ONE FOR YOUR LIPS CLEAR LIP BALM SPF 50 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RICE GERM (UNII: 7N2B70SFEZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SQUALANE (UNII: GW89575KF9)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
OCTYLDODECANOL (UNII: 461N1O614Y)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LEVOMENOL (UNII: 24WE03BX2T)
KONJAC MANNAN (UNII: 36W3E5TAMG)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BENZYL BENZOATE (UNII: N863NB338G)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-806-01	1 in 1 CARTON	02/01/2024
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - Kao USA Inc. (004251617)