HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY- zinc oxide stick

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY by

Drug Labeling and Warnings

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY 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

ZINC OXIDE 22.95%

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

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

Product Packaging

INGREDIENTS AND APPEARANCE

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	229.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ISOSTEARIC ACID (UNII: X33R8U0062)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
CI 45410 (UNII: 767IP0Y5NH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
HYALURONIC ACID (UNII: S270N0TRQY)
IRON OXIDES (UNII: 1K09F3G675)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CASTOR OIL (UNII: D5340Y2I9G)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CANDELILLA WAX (UNII: WL0328HX19)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-001-01	1 in 1 CARTON	11/12/2024
1		5.2 g 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	11/12/2024

Labeler - Kao USA Inc. (004251617)