SUN-KISSED SUNCREAM- octinoxate, octisalate, zinc oxide cream

Sun-Kissed Suncream by

Drug Labeling and Warnings

Sun-Kissed Suncream by is a Otc medication manufactured, distributed, or labeled by LEE & GEN GLOBAL CORPORATION, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

OCTINOXATE 7.5%
OCTISALATE 3.0%
ZINC OXIDE 8.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

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

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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

Protect the product in this container from excessive heat and direct sunlight

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN-KISSED SUNCREAM 
octinoxate, octisalate, zinc oxide cream

Product 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)