FDA.reportPublic FDA data

KIDS ® SPF30 SUPER SENSITIVE™+C111 SUNSCREEN LOTION

Manufacturer
ORGANIC & SUSTAINABLE BEAUTY
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:49

Label at a glance#

ProductKIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply – after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours 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 su...

Storage and handling

Protect the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use: on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

OTC - WHEN USING SECTION

When using this product: keep out of eyes. Rinse with water to remove.

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 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, isoamyl laurate, coco-caprylate, calendula officinalis extract (calendula), viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, mica, allantoin, panthenol.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA KIDS®

TINTED

#supersensitive™

30+
SUNSCREEN LOTION

HIGH PROTECTION

NO ADDED FRAGRANCE

BROAD SPECTRUM
SPF 30+ SUNSCREEN
WATER RESISTANT (80 MINUTES)

FOR BABIES, KIDS + ADULTS
WITH SENSITIVE SKIN

ALLERGY
TESTED

© 2018
NET WT 82 g/2.9 oz.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label
PRINCIPAL DISPLAY PANEL - 82 g Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-068-29KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN82 g in 1 TUBELOTION822

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-068KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN (TITANIUM DIOXIDE) LOTION [ORGANIC & SUSTAINABLE BEAUTY]2Current NDC, Legacy NDC, 1 package rows20241108_20ebe264-2f79-4eef-b83d-3f09a3ca2898.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-06852915-068-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
Water059QF0KO0RIACT
isoamyl laurateM1SLX00M3MIACT
coco-caprylate4828G836N6IACT
calendula officinalis flowerP0M7O4Y7YDIACT
VIOLA TRICOLOR WHOLE9Q24RAI43VIACT
polyglyceryl-2 dipolyhydroxystearate9229XJ4V12IACT
CANDELILLA WAXWL0328HX19IACT
STARCH, RICE4DGK8B7I3SIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
polyglyceryl-3 diisostearate46P231IQV8IACT
levulinic acidRYX5QG61EIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STARCH, TAPIOCA24SC3U704IIACT
ROSEMARYIJ67X351P9IACT
COCONUT OILQ9L0O73W7LIACT
squalaneGW89575KF9IACT
magnesium stearate70097M6I30IACT
p-anisic acid4SB6Y7DMM3IACT
allantoin344S277G0ZIACT
micaV8A1AW0880IACT
panthenolWV9CM0O67ZIACT

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
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
ndc (package): 52915-068-29
ndc (product): 52915-068
ndc11 (package): 52915006829
spl id: b198dfe6-503e-48b8-b253-f94c55937a84
spl set id: 20ebe264-2f79-4eef-b83d-3f09a3ca2898

Reported adverse events (FAERS/openFDA)#

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