FDA.reportPublic FDA data

SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25

Manufacturer
SMASHBOX BEAUTY COSMETICS, INC | Estee Lauder Companies Inc. | PALC | Estee Lauder Cosmetics Ltd. | Northtec LLC
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:48:47

Label at a glance#

ProductSMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

For sunscreen use: apply liberally and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: limit ...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.7%
Titanium Dioxide 3.1%
Zinc Oxide 1.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 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
    • children under 6 months of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water\Aqua\Eau, Octyldodecyl Neopentanoate, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Methyl Trimethicone, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethyl-siloxyethyl Dimethicone, Diethylhexyl Succinate, Laureth-4, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Rosa Hybrid Flower Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lycium Chinense (Wolfberry) Fruit Extract, Palmitoyl Hexapeptide-14, Peat Extract, Gold, Sodium Lactate, Methicone, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Glycerin, Barium Sulfate, Magnesium Sulfate, Dimethyl Isosorbide, Maltodextrin, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Silica, Aluminum Hydroxide, Dimethicone/PEG-10/15 Crosspolymer, Trimethylsiloxysilicate, Hexylene Glycol, Isostearic Acid, Caprylyl Glycol, Stearic Acid, Polyglyceryl-2 Triisostearate, Dipentaerythrityl Tri-Polyhydroxystearate, Dipropylene Glycol, Sodium Citrate, BHT, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Bismuth Oxychloride (CI 77163)] <ILN48115>

Other Information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smashbox
HALO

HEALTHY GLOW
ALL-IN-ONE
TINTED MOISTURIZER
BROAD SPECTRUM SPF 25

1.4 fl. oz./ 40 ml ℮

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-018-01SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 2540 mL in 1 TUBELIQUID4011
10348-018-01SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 251 in 1 CARTONLIQUID111
10348-018-02SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 257 mL in 1 TUBELIQUID711
10348-018-03SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 2512 mL in 1 TUBELIQUID1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10348-018SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25 (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LIQUID [SMASHBOX BEAUTY COSMETICS, INC]11Legacy NDC, 4 package rows20241227_757f5460-8e3d-4d30-bc90-196a1ab3b5fb.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10348-01810348-018-01, 10348-018-02, 10348-018-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
NIACINAMIDE25X51I8RD4IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
LAURETH-46HQ855798JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
APPLEB423VGH5S9IACT
LENS CULINARIS FRUITZYZ076G9JHIACT
WATERMELON231473QB6RIACT
GOLD79Y1949PYOIACT
SODIUM LACTATETU7HW0W0QTIACT
METHICONE (20 CST)6777U11MKTIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
GLYCERINPDC6A3C0OXIACT
BARIUM SULFATE25BB7EKE2EIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
MALTODEXTRIN7CVR7L4A2DIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ISOSTEARIC ACIDX33R8U0062IACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARIC ACID4ELV7Z65APIACT
POLYGLYCERYL-2 TRIISOSTEARATE68DUY2D39AIACT
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATED21K655H52IACT
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML · Source PDF

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
2a15cc43-7dd0-a11b-e063-6294a90a4496757f5460-8e3d-4d30-bc90-196a1ab3b5fb2024-12-25WarningsExact identifier
spl id: 2a15cc43-7dd0-a11b-e063-6294a90a4496
spl set id: 757f5460-8e3d-4d30-bc90-196a1ab3b5fb

Reported adverse events (FAERS/openFDA)#

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