DEAR SUN TONE PERFECTING SPF CUSHION- homosalate, octisalate, octocrylene, zinc oxide cream

Dear Sun Tone Perfecting SPF Cushion by

Drug Labeling and Warnings

Dear Sun Tone Perfecting SPF Cushion by is a Otc medication manufactured, distributed, or labeled by RBGROUP Co., Ltd, Cit Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 10.00%

Octisalate 3.00%

Octocrylene 2.00%

Zinc Oxide 13.30%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

If used as directed with other sun protection ,easure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

DOSAGE & ADMINISTRATION

■ apply liberally 15 minutes before sun exposure
■ use a water resistant sunscreen if swimming or sweating.

■ reapply at least every 2 hours.

■ children under 6 months of age: ask a doctor

■ 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

WARNINGS

■ For external use only

■ Do not useon demaged or broken skin. 

■ Stop use and ask a doctorif rash occurs.

■ When using this productkeep 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Cyclopentasiloxane, Silica, Sodium Chloride, Polyhydroxystearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Ceresin, Fragrance, Propylene Carbonate, Trihydroxystearin, Ethylhexylglycerin, Caprylyl Glycol, Butylene Glycol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Centella Asiatica Extract, Sucrose Stearate, Iron Oxides (CI 77492), Cetearyl Alcohol, Iron Oxides (CI 77491), Tocopherol, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sunlight

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEAR SUN TONE PERFECTING SPF CUSHION 
homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84326-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
SUCROSE STEARATE (UNII: 274KW0O50M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
MADECASSIC ACID (UNII: M7O1N24J82)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84326-001-02	1 in 1 CARTON	10/01/2024
1	NDC: 84326-001-01	15 g in 1 CONTAINER; 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	10/01/2024

Labeler - RBGROUP Co., Ltd (987610097)

Registrant - RBGROUP Co., Ltd (987610097)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	manufacture(84326-001)