FDA.reportPublic FDA data

Naturium Phyto-Glow Lip Balm SPF 45-Clear

Manufacturer
e.l.f. Cosmetics, Inc.
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:36

Label at a glance#

ProductNaturium Phyto-Glow Lip Balm SPF 45-Clear
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure8 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 liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use 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 Board Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially fro...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 3%

Octisalate 5%

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 liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
  • Use 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 Board 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 of age: ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

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

InactiveIngredients

INACTIVE INGREDIENT SECTION

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Aroma/Flavor, Polyglyceryl-2 Diisostearate, Butyrospermum Parkii (Shea) Butter, Cera Microcristallina/Microcrystalline Wax/Cire Microcristalline, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Synthetic Wax, Mica, Squalane, Theobroma Grandiflorum Seed Butter, Siraitia Grosvenorii Fruit Extract, Tocopherol, Citric Acid, BHT, Carvone, Cinnamal, Eugenol, Limonene, Menthol, Methyl Salicylate, Vanillin.

Questions?

OTC - QUESTIONS SECTION

1-888-315-9814

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging Label-ClearPackaging Label-Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-135-01Naturium Phyto-Glow Lip Balm SPF 45-Clear1 in 1 CARTONCREAM11
76354-135-01Naturium Phyto-Glow Lip Balm SPF 45-Clear10 mL in 1 TUBECREAM101

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-13576354-135-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-2 DIISOSTEARATEDG195GP57PIACT
SIRAITIA GROSVENORII FRUITNOU2FB51TWIACT
CITRIC ACID2968PHW8QPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
BHT1P9D0Z171KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
METHYL SALICYLATELAV5U5022YIACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE8N725H4EFNIACT
EUGENOL3T8H1794QWIACT
VANILLINCHI530446XIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
CARVONE75GK9XIA8IIACT
MICAV8A1AW0880IACT
HOMOSALATEV06SV4M95SACTIB
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SQUALANEGW89575KF9IACT
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
MENTHOLL7T10EIP3AIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
OCTISALATE4X49Y0596WACTIB
CINNAMALSR60A3XG0FIACT

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
Naturium Phyto-Glow Lip Balm SPF 45-ClearAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3806e2f2-ffd1-6d69-e063-6394a90acb442025-06-09WarningsExact identifier
ndc (package): 76354-135-01
ndc (product): 76354-135
ndc11 (package): 76354013501
spl id: 3806e420-2353-3b61-e063-6294a90a8680
spl set id: 3806e2f2-ffd1-6d69-e063-6394a90acb44

Reported adverse events (FAERS/openFDA)#

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