HELLO SUNDAY THE SHIMMER ONE MINERAL GLOW SPF 45- zinc oxide stick

Hello Sunday The Shimmer One Mineral Glow SPF 45 by

Drug Labeling and Warnings

Hello Sunday The Shimmer One Mineral Glow SPF 45 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 21.73%

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.

Directions

• Twist the shimmer stick up slightly so that the stick is above the base, remove the plastic dust cap, and twist the shimmer stick back down for optimal usage. Swipe generously on dry face & body, then blend in for a subtle glow. Use over any other Hello Sunday SPF

product and as the last step in your skincare routine (under or over makeup) 15 minutes before sun exposure.

• Reapply SPF protection every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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
• Children under 6 months of age: Ask a doctor.

Warnings

For external use only

Do not use

on damaged or broken skin

Stop use and ask a doctor if

rash occurs

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ingredients

C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOSTEARYL ISOSTEARATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, OCTYLDODECANOL, BUTYLOCTYL SALICYLATE, TRIBEHENIN, DIISOSTEARYL MALATE, MICA, SILICA, POLYHYDROXYSTEARIC ACID, STEARALKONIUM BENTONITE, CALCIUM ALUMINUM BOROSILICATE, SODIUM HYALURONATE, GLYCINE SOJA (SOYBEAN) OIL, TETRAHEXYLDECYL ASCORBATE, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, ETHYLHEXYL PALMITATE, MALIC ACID, TOCOPHEROL, PHYSALIS ANGULATA EXTRACT, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, CAPRYLYL GLYCOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TIN OXIDE, TRIHYDROXYSTEARIN, GLUCOMANNAN, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491)

Product Packaging

INGREDIENTS AND APPEARANCE

HELLO SUNDAY THE SHIMMER ONE MINERAL GLOW SPF 45 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	217.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RICE GERM (UNII: 7N2B70SFEZ)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MALIC ACID (UNII: 817L1N4CKP)
KONJAC MANNAN (UNII: 36W3E5TAMG)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-805-01	20 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2024

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)