LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN- zinc oxide lotion

LUXURY SUN RITUAL by

Drug Labeling and Warnings

LUXURY SUN RITUAL by is a Otc medication manufactured, distributed, or labeled by JANE STREET LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 10%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

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 USE AND ASK A DOCTOR IF RASH OCCURS.

• KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
• CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
• USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
• REAPPLY 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.

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

Water, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cetearyl Alcohol, Cetearyl Olivate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Jasminum Officinale (Jasmine) Extract, Hibiscus Sabdariffa Flower Extract, Adenium Obesum (Desert Rose) Extract, Cetearyl Glucoside, Triethoxycaprylylsilane, Camellia Sinensis (Green Tea) Leaf Oil, Tocopheryl Acetate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUXURY SUN RITUAL  PORE SMOOTHING SPF 30 SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82404-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN OLIVATE (UNII: MDL271E3GR)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ADENIUM OBESUM WHOLE (UNII: SH5EDD5OZA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82404-101-12	1 in 1 BOX	05/01/2022
1	NDC: 82404-101-11	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82404-101-13	3 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2022
3	NDC: 82404-101-15	1 in 1 BOX	12/01/2022
3	NDC: 82404-101-14	25 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 Drug	M020	05/01/2022

Labeler - JANE STREET LLC (081575951)