Label: SUN PROJECT WATER SUN CREAM SPF50- octinoxate, homosalate, octisalate, octocrylene, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70618-006-01, 70618-006-02 - Packager: THANK YOU FARMER CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 12, 2021
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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. 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, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclomethicone, Alcohol, Glyceryl Stearate, 1,2-Hexanediol, Behenyl Alcohol, Methyl Methacrylate Crosspolymer, Peg-100 Stearate, Viscum Album (Mistletoe) Leaf Extract, Centella Asiatica Extract, Portulaca Oleracea Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Phenoxyethanol, Aluminum Stearate, Polyhydroxystearic Acid, Octyldodecanol, Fragrance, Bambusa Vulgaris Water, Xanthan Gum, Alumina, Echium Plantagineum Seed Oil, Glycine Soja (Soybean) Lipids, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Plukenetia Volubilis Seed Oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN PROJECT WATER SUN CREAM SPF50
octinoxate, homosalate, octisalate, octocrylene, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70618-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.4 mg in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 mg in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.25 mg in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.7 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) ALCOHOL (UNII: 3K9958V90M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DOCOSANOL (UNII: 9G1OE216XY) PEG-100 STEARATE (UNII: YD01N1999R) VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) CENTELLA ASIATICA (UNII: 7M867G6T1U) PURSLANE (UNII: M6S840WXG5) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM STEARATE (UNII: U6XF9NP8HM) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) OCTYLDODECANOL (UNII: 461N1O614Y) BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ) CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70618-006-02 1 in 1 CARTON 04/08/2016 1 NDC:70618-006-01 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 OTC monograph not final part352 04/08/2016 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. Gwanjeong Factory 689512611 manufacture(70618-006)
