Label: DEAR SUN TONE PERFECTING SPF CUSHION- homosalate, octisalate, octocrylene, zinc oxide cream
- NDC Code(s): 84326-001-01, 84326-001-02
- Packager: RBGROUP Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEAR SUN TONE PERFECTING SPF CUSHION
homosalate, octisalate, octocrylene, zinc oxide creamProduct 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)

