HOUSE OF COLOUR TINTED SUNSCREEN SPF 50- zinc oxide cream

House of Colour Tinted Sunscreen SPF 50 by

Drug Labeling and Warnings

House of Colour Tinted Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by House of Colour, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide 24%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

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 liberally 15 minutes before sun exposure
• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. 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
• reapply at least every 2 hours 
• use a water resistant sunscreen if swimming or sweating 
• 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

Hydroxyacetophenone, Water, Panthenol, Argan Oil, C10-18 Triglycerides, Medium Chain Triglycerides, Iron Oxides, Isododecane, Polyglyceryl-6 Polyhydroxystearate, Polyhydroxystearic acid, Tocopherol, VP/Eicosene Copolymer, Glycerin, Magnesium Sulfate, Niacinamide, Tocopheryl Acetate, Trihydroxystearin , 1,2-Hexanediol, Bisabolol, Caprylyl Glycol, Allantoin, Ascorbyl Palmitate, Green Tea Leaf Extract, Coco-caprylate, Glyceryl Behenate, Polyglyceryl-6 Polyricinoleate, Triethoxycaprylylsilane.

Package Labeling:

INGREDIENTS AND APPEARANCE

HOUSE OF COLOUR TINTED SUNSCREEN SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85242-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	240 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
ARGAN OIL (UNII: 4V59G5UW9X)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISODODECANE (UNII: A8289P68Y2)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE (UNII: DE08037SAB)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCO-CAPRYLATE (UNII: 4828G836N6)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85242-000-00	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/10/2025

Labeler - House of Colour, Inc. (119379715)

Registrant - House of Colour, Inc. (119379715)