FDA.reportPublic FDA data

SPF Elio Drops 30 Glow

Manufacturer
Allure Labs Inc
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:10

Label at a glance#

ProductSPF Elio Drops 30 Glow
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS...………... ZINC OXIDE 15.6%

OTC - PURPOSE SECTION

PURPOSE........................SUNSCREEN

INDICATIONS & USAGE SECTION

USES: HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS SECTION

WARNINGS FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

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 SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, CAPRYLIC/CAPRIC, TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLY, SILANE, LECITHIN, HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE, CAPRATE, HYDRATED SILICA, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, POLYGLYCERYL-6 POLYRICINOLEATE, DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, PRUNUS ARMENIACA, KERNEL OIL, CASTOR OIL/IPDI COPOLYMER, ALOE BARBADENESIS LEAF EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL, MAY CONTAIN +/- IRON OXIDES (CI 77492, CI 77491, CI 77499

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPFEliodrops30GlowSPFEliodrops30Glow

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4233-1SPF Elio Drops 30 Glow29.4 g in 1 TUBECREAM29.41
62742-4233-2SPF Elio Drops 30 Glow1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4233SPF ELIO DROPS 30 GLOW (ZINC OXIDE) CREAM [ALLURE LABS INC]1Current NDC, 2 package rows20231030_08cbf8d6-8c27-1567-e063-6394a90a932e.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-423362742-4233-1, 62742-4233-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERIN-34A0NCJ6RD6IACT
HYDROGENATED RAPESEED OILK168T6Y0YUIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
COCO-CAPRYLATE4828G836N6IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SQUALANEGW89575KF9IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYDROGENATED PALM OIL257THB963HIACT
SILANE5J076063R1IACT
ALOE VERA LEAFZY81Z83H0XIACT
SAFFLOWER OIL65UEH262ISIACT
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDEFJ1H6M2JG9IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DILINOLEIC ACID/BUTANEDIOL COPOLYMER1F2S8T535OIACT
ISODODECANEA8289P68Y2IACT
CAMELLIA OILT1PE06G0VEIACT
APRICOT KERNEL OIL54JB35T06AIACT
CASTOR OILD5340Y2I9GIACT
ARGAN OIL4V59G5UW9XIACT
PISTACIA LENTISCUS RESIN OILZJ39788YVAIACT
PROPANEDIOL DICAPRYLATE/CAPRATEF53961BX4FIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
RED BREAST CICHLID492WK4ZA3BIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
HYDRATED SILICAY6O7T4G8P9IACT
GINGERC5529G5JPQIACT
LEVOMENOL24WE03BX2TIACT

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
SPF Elio Drops 30 GlowZINC OXIDEAllure Labs Inc08cbf8d6-8c27-1567-e063-6394a90a932e2023-10-28WarningsExact identifier
ndc (package): 62742-4233-1
ndc (package): 62742-4233-2
ndc (product): 62742-4233
ndc11 (package): 62742423302
ndc11 (package): 62742423301
spl id: 08cbf8d6-8c28-1567-e063-6394a90a932e
spl set id: 08cbf8d6-8c27-1567-e063-6394a90a932e

Reported adverse events (FAERS/openFDA)#

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