HELLO SUNDAY THE INVISIBLE ONE SUNSCREEN PLUS PRIMER SPF 50- avobenzone, homosalate, octisalate, octocrylene emulsion

Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50 by

Drug Labeling and Warnings

Hello Sunday The Invisible One Sunscreen Plus Primer 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

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.

Directions

• Apply generously on dry skin (we recommend 1 teaspoon’s worth), 15 minutes before sun exposure and as a last step in your skincare routine (before makeup). Reapply every 2 hours.
• Reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every two hours
• 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.

Other Information

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

Inactive Ingredients

ACRYLATES CROSSPOLYMER, COCO-CAPRYLATE/CAPRATE, TRIHEPTANOIN, C9-12 ALKANE, BUTYLOCTYL SALICYLATE, DILINOLEIC ACID/BUTANEDIOL COPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, VP/EICOSENE COPOLYMER, ARGANIA SPINOSA KERNEL OIL, SODIUM HYALURONATE, TOCOPHERYL ACETATE, GLYCINE SOJA (SOYBEAN) OIL, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, TETRAHEXYLDECYL ASCORBATE, PONGAMIA GLABRA SEED OIL, BISABOLOL, PHYSALIS ANGULATA EXTRACT, DUNALIELLA SALINA EXTRACT, HAEMATOCOCCUS PLUVIALIS EXTRACT, TOCOPHEROL, CASTOR OIL/IPDI COPOLYMER, CAPRYLYL GLYCOL, DIETHYLHEXYL SYRINGYLIDENEMALONATE, ETHYLHEXYL PALMITATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN

Questions or comments?

1-888-426-0695
Monday-Friday, 9 a.m. - 5 p.m. EST

Product Packaging

INGREDIENTS AND APPEARANCE

HELLO SUNDAY THE INVISIBLE ONE SUNSCREEN PLUS PRIMER SPF 50 
avobenzone, homosalate, octisalate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-801
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RICE GERM (UNII: 7N2B70SFEZ)
KARUM SEED OIL (UNII: 62160PU6FJ)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
ARGAN OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LEVOMENOL (UNII: 24WE03BX2T)
KONJAC MANNAN (UNII: 36W3E5TAMG)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
C9-12 ALKANE (UNII: 7J5R5W72QM)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-801-01	1 in 1 CARTON	02/01/2024
1		50 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)