FDA.reportPublic FDA data

Halo Glow Skin Tint SPF 50 84504

Manufacturer
e.l.f. Cosmetics, Inc.
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:19

Label at a glance#

ProductHalo Glow Skin Tint SPF 50 84504
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

Apply generously and evenly 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: L...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 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 sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION


Water, C12-15 Alkyl Benzoate, Isododecane, Lauryl PEG-8 Dimethicone, Tridecyl Salicylate, Calcium Sodium Borosilicate, Propanediol, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Niacinamide, C13-15 Alkane, Silica, Octyldodecyl Neopentanoate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Sodium Chloride, Disteardimonium Hectorite, Phenoxyethanol, Bisabolol, Lecithin, Caprylyl Glycol, Allantoin, Aluminum Hydroxide, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Ethylhexylglycerin, Hexylene Glycol, Hydrogenated Lecithin, Tetrasodium Glutamate Diacetate, Sodium Hydroxide

May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

OTC - QUESTIONS SECTION

1-888-315-9814

Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging LabelPackaging Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-550-01Halo Glow Skin Tint SPF 50 845041 in 1 CARTONLOTION13
76354-550-01Halo Glow Skin Tint SPF 50 8450430 mL in 1 TUBELOTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-550HALO GLOW SKIN TINT SPF 50 84504 (ZINC OXIDE) LOTION [E.L.F. COSMETICS, INC.]3Current NDC, 2 package rows20250506_223efabb-d018-c337-e063-6394a90a5605.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-55076354-550-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
LAURYL PEG-8 DIMETHICONE (300 CPS)ELL2U7K8T8IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
C13-15 ALKANE114P5I43UJIACT
.BETA.-BISABOLOLLP618AV2EAIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLYL TRIMETHICONEH6HK6E4EB1IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
FERRIC OXIDE RED1K09F3G675IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
NIACINAMIDE25X51I8RD4IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
Halo Glow Skin Tint SPF 50 84504ZINC OXIDEe.l.f. Cosmetics, Inc.223efabb-d018-c337-e063-6394a90a56052025-03-25WarningsExact identifier
ndc (package): 76354-550-01
ndc (product): 76354-550
ndc11 (package): 76354055001
spl id: 3135834f-ddd7-2cdc-e063-6394a90a6152
spl set id: 223efabb-d018-c337-e063-6394a90a5605

Reported adverse events (FAERS/openFDA)#

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