FDA.reportPublic FDA data

SPF30 SUPER SENSITIVE SUNSCREEN

Manufacturer
ORGANIC & SUSTAINABLE BEAUTY
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:26

Label at a glance#

ProductSPF30 SUPER SENSITIVE 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: 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 prot...

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 17%

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

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: 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

Oleyl erucate, euphorbia cerifera (candelilla) wax, copernicia cerifera (carnauba) wax , caprylic/capric triglyceride, coco-caprylate, rosmarinus officinalis (rosemary) leaf extract.

PRINCIPAL DISPLAY PANEL - 14 g Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY®
trusted since 1995

super sensitive™

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

NO ADDED FRAGRANCE • VEGAN • TEAR FREE
PHYSICAL BARRIER • CONCENTRATED
NO GLUTEN, SOY, OAT OR DAIRY

MINERAL BASED SUNSCREEN
• for babies • kids • sensitive adults •

Net Wt. 14 g / 0.5 Oz.

ALLERGY
TESTED

PRINCIPAL DISPLAY PANEL - 14 g Container Label
PRINCIPAL DISPLAY PANEL - 14 g Container Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52915-070-052020-11-06C16284748780-19855d018-e32d-cd31-e053-dbdaa90ab51aSPF30 SUPER SENSITIVE™ SUNSCREEN STICK
52915-070-052019-11-27C16284748780-19855d018-e32d-cd31-e053-dbdaa90ab51aSPF30 SUPER SENSITIVE™ SUNSCREEN STICK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-070-05SPF30 SUPER SENSITIVE SUNSCREEN14 g in 1 CONTAINERSTICK143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-070SPF30 SUPER SENSITIVE SUNSCREEN (TITANIUM DIOXIDE) STICK [ORGANIC & SUSTAINABLE BEAUTY]3Current NDC, Legacy NDC, 1 package rows20241109_fef47045-1d3c-4f08-acec-e96abefbc261.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
candelilla waxINACTIVE INGREDIENTWL0328HX191
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ1
coco-caprylateINACTIVE INGREDIENT4828G836N61
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U1
oleyl erucateINACTIVE INGREDIENT753W099NQ61
rosemaryINACTIVE INGREDIENTIJ67X351P91

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-07052915-070-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
oleyl erucate753W099NQ6IACT
candelilla waxWL0328HX19IACT
carnauba waxR12CBM0EIZIACT
medium-chain triglyceridesC9H2L21V7UIACT
coco-caprylate4828G836N6IACT
rosemaryIJ67X351P9IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
candelilla waxCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route
12 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZOINTMENT / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii+route
12 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii+route
12 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii+route
12 equally ranked IID candidates

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
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
ndc (package): 52915-070-05
ndc (product): 52915-070
ndc11 (package): 52915007005
spl id: 902e8a2e-9c89-4ac8-a842-008e279d1142
spl set id: fef47045-1d3c-4f08-acec-e96abefbc261

Reported adverse events (FAERS/openFDA)#

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