Label: SUN-KISSED SUNCREAM- octinoxate, octisalate, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 78493-001-01, 78493-001-02 - Packager: LEE & GEN GLOBAL CORPORATION
- Category: HUMAN OTC DRUG LABEL
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 May 5, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
For sunscreen use:
■ apply liberally 15 minutes before sun exposure
■ reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 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 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
■ children under 6 months of age: ask a doctor - WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Water, Cyclopentasiloxane, Ethylhexyl Isononanoate, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Phenoxyethanol, Sodium Chloride, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Iodopropynyl Butylcarbamate, Ascorbyl Palmitate, BHT, Retinyl Palmitate, Dipropylene Glycol, Zea Mays (Corn) Oil, Tocopherol
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUN-KISSED SUNCREAM
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78493-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) DIPROPYLENE GLYCOL (UNII: E107L85C40) CORN OIL (UNII: 8470G57WFM) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78493-001-02 1 in 1 CARTON 05/04/2022 1 NDC:78493-001-01 88.7 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 final part352 05/04/2022 Labeler - LEE & GEN GLOBAL CORPORATION (038129947) Registrant - LEE & GEN GLOBAL CORPORATION (038129947) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(78493-001)
