FDA.reportPublic FDA data

elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl

Manufacturer
e.l.f. Cosmetics, Inc.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:53

Label at a glance#

Productelf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl
Active ingredientZINC OXIDE
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

Zinc Oxide 10.0%

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

Polyisobutene, Pentaerythrityl Tetraethylhexanoate, Hydrogenated Polysiobutene, C12-15 Alkyl Benzoate, Octyldodecanol, Microcrystalline Wax (Cera Microcristallina), Butyloctyl Salicylate, Tridecyl Trimellitate, Silica Dimethyl Silylate, Oryzanol, Camellia Oleifera Seed Oil, Triethoxycaprylylsilane, Fragrance (Parfum), Ethylhexylglycerin, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Tocopheryl Acetate, Ricinus Communis (Castor) Seed Oil, Isostearic Acid, Sodium Hyaluronate, Polyglyceryl-3 Polyricinoleate, Lecithin, Hydrogenated Castor Oil, Tocopherol [+/-]: Titanium Dioxide (CI 77891), Iron Oxide (CI 77492), Iron Oxide (CI 77491), Red 7 Lake (CI 15850), Iron Oxide (CI 77499), Red 6 Lakes (CI 15850), Blue 1 Lake (CI 42090)

Questions?

OTC - QUESTIONS SECTION

1-888-315-9814

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube3Tube3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/beRJ2CTube3.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-126-01elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl4 mL in 1 TUBECREAM43
76354-126-01elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl1 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-12676354-126-01

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
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTYLDODECANOL461N1O614YIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ORYZANOLSST9XCL51MIACT
CAMELLIA OILT1PE06G0VEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CASTOR OILD5340Y2I9GIACT
ISOSTEARIC ACIDX33R8U0062IACT
HYALURONATE SODIUMYSE9PPT4THIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
D&C RED NO. 6481744AI4OIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ZINC OXIDESOI2LOH54ZACTIM

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
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
ndc (package): 76354-126-01
ndc (product): 76354-126
ndc11 (package): 76354012601
spl id: 452b13aa-b6f5-2c41-e063-6294a90a7632
spl set id: 6c316ce4-c2f6-4633-a789-e786d0f76abd

Reported adverse events (FAERS/openFDA)#

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