FDA.reportPublic FDA data

Self Defense Mineral Sunscreen Fluid SPF 34

Manufacturer
The Honest Company, Inc.
Effective date
2021-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:41

Label at a glance#

ProductSelf Defense Mineral Sunscreen Fluid SPF 34
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Titanium Dioxide 2%

Zinc Oxide 15.8%

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

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Shake well. Apply liberally and evenly 15 minutes before sun exposure and as needed.
  • 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 the 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

SPL UNCLASSIFIED SECTION

Other information ♦protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua/Eau), Dicaprylyl Carbonate, Carthamus Tinctorius (Safflower) Oleosomes, Propanediol,
Coconut Alkanes, Silica, C9-12 Alkane, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Cetyl Alcohol, Ectoin,
Sea Water, Allantoin, Glycerin, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol, Stearic Acid, Coco-Caprylate/Caprate, Gluconolactone, Trisodium Ethylenediamine Disuccinate, Sodium Benzoate, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

HONEST ®

SELF DEFENSE

MINERAL SUNSCREEN

FLUID SPF 34

UNDER COVER

Honest Sea Water™ + Zinc Oxide

+ Titanium Dioxide + Extremolyte

ALL SKIN TYPES

1.0 fl. oz. / 30 mL

JOIN US AT HONEST.COM or call

888-862-8818

©2021 Dist. by

The Honest Company, Inc.

Los Angeles, CA 90094

Made in USA from US and imported materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-226-272023-12-19C16284748780-10191ceaa-61b1-198a-e063-dbdaa90aec3eSelf Defense Mineral Sunscreen Fluid SPF 34
69366-226-272023-07-28C16284748780-10191ceaa-61b1-198a-e063-dbdaa90aec3eSelf Defense Mineral Sunscreen Fluid SPF 34

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
69366-22669366-226-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
PROPANEDIOL5965N8W85TIACT
COCONUT ALKANES1E5KJY107TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
ECTOINE7GXZ3858RYIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM HYDROXIDE55X04QC32IIACT
ZINC OXIDESOI2LOH54ZACTIM
DODECANE11A386X1QHIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SODIUM BENZOATEOJ245FE5EUIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALLANTOIN344S277G0ZIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
STEARIC ACID4ELV7Z65APIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLUCONOLACTONEWQ29KQ9POTIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT

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
eea41a16-8630-7075-e053-2a95a90ac76ac19b83e5-c218-0cb0-e053-2995a90a73fc2023-12-05WarningsExact identifier
spl set id: c19b83e5-c218-0cb0-e053-2995a90a73fc

Reported adverse events (FAERS/openFDA)#

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