Label: SUN PROJECT SKIN-RELIEF SUNCREAM- diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol, diethylhexyl butamido triazone cream
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- NDC Code(s): 70618-010-01, 70618-010-02
- 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 30, 2022
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- 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
WATER, DIBUTYL ADIPATE, PROPANEDIOL, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, COCO-CAPRYLATE/CAPRATE, CAPRYLYL METHICONE, GLYCERIN, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, BEHENYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, DECYL GLUCOSIDE, TROMETHAMINE, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, ETHYLHEXYLGLYCERIN, ADENOSINE, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, T-BUTYL ALCOHOL, TOCOPHEROL, SALVIA HISPANICA SEED EXTRACT, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, ANASTATICA HIEROCHUNTICA EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, GARDENIA JASMINOIDES FRUIT EXTRACT, FORSYTHIA SUSPENSA FRUIT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, COPTIS JAPONICA ROOT EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN PROJECT SKIN-RELIEF SUNCREAM
diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol, diethylhexyl butamido triazone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70618-010 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 1.5 mg in 50 mL ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE 1.2 mg in 50 mL BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS) BISOCTRIZOLE 1 mg in 50 mL ISCOTRIZINOL (UNII: 2UTZ0QC864) (ISCOTRIZINOL - UNII:2UTZ0QC864) ISCOTRIZINOL 0.6 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIBUTYL ADIPATE (UNII: F4K100DXP3) PROPANEDIOL (UNII: 5965N8W85T) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) NIACINAMIDE (UNII: 25X51I8RD4) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PENTYLENE GLYCOL (UNII: 50C1307PZG) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) TROMETHAMINE (UNII: 023C2WHX2V) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ADENOSINE (UNII: K72T3FS567) XANTHAN GUM (UNII: TTV12P4NEE) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) TOCOPHEROL (UNII: R0ZB2556P8) CHIA SEED (UNII: NU0OLX06F8) EGGPLANT (UNII: W5K7RAS4VK) ANASTATICA HIEROCHUNTICA WHOLE (UNII: SU125S6473) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) COPTIS JAPONICA ROOT (UNII: JH0SWT16D1) GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70618-010-02 1 in 1 CARTON 05/30/2022 1 NDC:70618-010-01 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 unapproved drug other 05/30/2022 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(70618-010)
