Label: SUN PROJECT SILKY CALMING SUN STICK- diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, polysilicone-15, bis-ethylhexyloxyphenol methoxyphenyl triazine stick
- NDC Code(s): 70618-011-01, 70618-011-02
- Packager: THANK YOU FARMER CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 31, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglassesAsk a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
METHYL METHACRYLATE CROSSPOLYMER, POLYETHYLENE, CAPRYLYL METHICONE, COCO-CAPRYLATE/CAPRATE, ETHYLHEXYL PALMITATE, ISOPROPYL PALMITATE, DICAPRYLYL CARBONATE, SYNTHETIC FLUORPHLOGOPITE, DIBUTYL ADIPATE, OZOKERITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, VINYL DIMETHICONE, FRAGRANCE, GLYCERYL CAPRYLATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, CALAMINE, WATER, MADECASSIC ACID, ASIATICOSIDE, ASIATIC ACID, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN PROJECT SILKY CALMING SUN STICK
diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, polysilicone-15, bis-ethylhexyloxyphenol methoxyphenyl triazine stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70618-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 0.49 g in 14 g ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE 0.42 g in 14 g POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-15 0.28 g in 14 g BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 0.21 g in 14 g Inactive Ingredients Ingredient Name Strength METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) DIBUTYL ADIPATE (UNII: F4K100DXP3) CERESIN (UNII: Q1LS2UJO3A) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) MADECASSIC ACID (UNII: M7O1N24J82) ASIATICOSIDE (UNII: PKO39VY215) ASIATIC ACID (UNII: 9PA5A687X5) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70618-011-02 1 in 1 CARTON 05/31/2022 1 NDC:70618-011-01 14 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 unapproved drug other 05/31/2022 Labeler - THANK YOU FARMER CO., LTD. (689605142) Registrant - THANK YOU FARMER CO., LTD. (689605142) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(70618-011)