FORMOLOGY (as CMO) SJ LUXURY SUN RITUAL (72580-109)

LUXURY BODY RITUAL by

Drug Labeling and Warnings

LUXURY BODY RITUAL by is a Otc medication manufactured, distributed, or labeled by Formology Lab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUXURY BODY RITUAL HYDRATING SPF 30- zinc oxide lotion 
Formology Lab Inc.

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FORMOLOGY (as CMO) SJ LUXURY SUN RITUAL (72580-109)

ACTIVE INGREDIENT

ZINC OXIDE 11%

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, Caprylic/Capric Triglyceride, Dimethicone, Butylene Glycol, Sodium Olivate, Silica, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Nymphaea Coerulea (Blue Lotus) Flower Extract, Orchis Maculata (Spotted Orchid) Flower Extract, Passiflora Edulis (Passion Fruit) Extract, Camellia Sinensis (Green Tea) Leaf Oil, Potassium Cetyl Phosphate, Stearic Acid, Xylitylglucoside, Anhydroxylitol, Cetearyl Glucoside, Triethoxycaprylylsilane, Xylitol, Tocopheryl Acetate, Xanthan Gum, Caprylhydroxamic Acid, Glycerin, Citric Acid, Pongamia Pinnata Seed Extract

LUXURY BODY RITUAL  HYDRATING SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72580-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM OLIVATE (UNII: ND5Y5M6ZUT)
DACTYLORHIZA MACULATA FLOWER (UNII: G1H83709QF)
NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
XANTHAN GUM (UNII: TTV12P4NEE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITOL (UNII: VCQ006KQ1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
PASSIFLORA EDULIS FRUIT (UNII: 602YE42W5R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72580-109-12	1 in 1 BOX	05/01/2024
1	NDC: 72580-109-11	120 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	05/01/2024

Labeler - Formology Lab Inc. (081102403)

Revised: 4/2024

Document Id: 1d6529c0-e068-c8a6-e063-6394a90a608d

34390-5

Set id: 1d6529ae-980a-592c-e063-6294a90aa1ea

Version: 1

Effective Time: 20240416