FDA.reportPublic FDA data

LUXURY BODY RITUAL

Manufacturer
Formology Lab Inc.
Effective date
2024-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:58:47

Label at a glance#

ProductLUXURY BODY RITUAL HYDRATING SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

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 MEASU...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SJ_LuxuryBodySPF_Secondary_111423_OL (DFB).jpgSJ_LuxuryBodySPF_Secondary_111423_OL (DFB).jpgZINC OXIDE 11%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USE

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.

OTC - DO NOT USE SECTION

  • DO NOT USE ON DAMAGED OR BROKEN SKIN.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

OTC - STOP USE SECTION

  • STOP USE AND ASK A DOCTOR IF RASH OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SJ_LuxuryBodySPF_Secondary_111423_OL (PDP).jpgSJ_LuxuryBodySPF_Secondary_111423_OL (PDP).jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72580-109LUXURY BODY RITUAL HYDRATING SPF 30 (ZINC OXIDE) LOTION [FORMOLOGY LAB INC.]1Unmatched20240718_1d6529ae-980a-592c-e063-6294a90aa1ea.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72580-10972580-109-11, 72580-109-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM OLIVATEND5Y5M6ZUTIACT
DACTYLORHIZA MACULATA FLOWERG1H83709QFIACT
NYMPHAEA CAERULEA FLOWERS9560USZ74IACT
SORBITAN OLIVATEMDL271E3GRIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETEARYL OLIVATE58B69Q84JOIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
XANTHAN GUMTTV12P4NEEIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
STEARIC ACID4ELV7Z65APIACT
XYLITOLVCQ006KQ1EIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
ANHYDROXYLITOL8XWR7NN42FIACT
PASSIFLORA EDULIS FRUIT602YE42W5RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1d6529c0-e068-c8a6-e063-6394a90a608d1d6529ae-980a-592c-e063-6294a90aa1ea2024-04-16WarningsExact identifier
spl id: 1d6529c0-e068-c8a6-e063-6394a90a608d
spl set id: 1d6529ae-980a-592c-e063-6294a90aa1ea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.