FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Arbonne International, LLC
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:15

Label at a glance#

ProductABC Arbonne Baby Care Sunscreen Broad Spectrum SPF 30 Water-Resistant (40 Minutes)
Active ingredientZINC OXIDE
Label structure11 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: after 40 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 the...

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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.4%

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

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 40 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 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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, caprylic/capric triglyceride, coco-caprylate, polyglyceryl-2 dipolyhydroxystearate, dicaprylyl carbonate, polyglyceryl-4 isostearate, cetyl dimethicone, glycerin, copernicia cerifera (carnauba) wax, cetyl alcohol, euphorbia cerifera (candelilla) wax, tapioca starch, calendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, triethoxycaprylylsilane, tocopheryl acetate, magnesium sulfate, sodium chloride, silica dimethyl silylate, stearic acid, chlorphenesin, phenoxyethanol.

Questions or comments?

OTC - QUESTIONS SECTION

1.800.272.6663

Monday–Friday 6 a.m.–6 p.m. Pacific time

SPL UNCLASSIFIED SECTION

Distributed by
Arbonne International, LLC
Greenwood, IN 46143 USA

PRINCIPAL DISPLAY PANEL - 177 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ABC
ARBONNE BABY CARE ®

SUNSCREEN
BROAD SPECTRUM SPF 30

WATER-RESISTANT
(40 Minutes)

6 fl. oz./177 mL

ABC Sunscreen SPF 30 LabelABC Sunscreen SPF 30 Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42508-332-02ABC Arbonne Baby Care Sunscreen Broad Spectrum SPF 30 Water-Resistant (40 Minutes)177 mL in 1 TUBELOTION1772
42508-332-02ABC Arbonne Baby Care Sunscreen Broad Spectrum SPF 30 Water-Resistant (40 Minutes)1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42508-332ABC ARBONNE BABY CARE SUNSCREEN BROAD SPECTRUM SPF 30 WATER-RESISTANT (40 MINUTES) (ZINC OXIDE) LOTION [ARBONNE INTERNATIONAL, LLC]22 package rows20241115_dab14650-50d2-4c56-ba7a-421f63dfe394.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42508-33242508-332-02

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
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE4828G836N6IACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
GLYCERINPDC6A3C0OXIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
CANDELILLA WAXWL0328HX19IACT
STARCH, TAPIOCA24SC3U704IIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
STEARIC ACID4ELV7Z65APIACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB

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
26ba0bf3-1c36-50c6-e063-6394a90ae351dab14650-50d2-4c56-ba7a-421f63dfe3942024-11-12WarningsExact identifier
spl id: 26ba0bf3-1c36-50c6-e063-6394a90ae351
spl set id: dab14650-50d2-4c56-ba7a-421f63dfe394

Reported adverse events (FAERS/openFDA)#

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