FDA.reportPublic FDA data

SPF30+ SUPER SENSITIVE™ SUNSCREEN LOTION

Manufacturer
ORGANIC & SUSTAINABLE BEAUTY
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:36:18

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 prote...

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.

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

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, allantoin, panthenol.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALIF♥RNIA BABY®
TRUSTED SINCE 1995

super sensitive™

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52915-050-292020-11-06C16284748780-19d75b9d0-fdf9-f424-e053-dadaa90a57ceSPF30+ SUPER SENSITIVE™ SUNSCREEN LOTION
52915-050-292020-01-31C16284748780-19d75b9d0-fdf9-f424-e053-dadaa90a57ceSPF30+ SUPER SENSITIVE™ SUNSCREEN LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-050-05SPF30 SUPER SENSITIVE SUNSCREEN14 g in 1 TUBELOTION/SHAMPOO145
52915-050-06SPF30 SUPER SENSITIVE SUNSCREEN170 g in 1 TUBELOTION/SHAMPOO1705
52915-050-18SPF30 SUPER SENSITIVE SUNSCREEN51 g in 1 TUBELOTION/SHAMPOO515
52915-050-19SPF30 SUPER SENSITIVE SUNSCREEN562 g in 1 TUBELOTION/SHAMPOO5625
52915-050-29SPF30 SUPER SENSITIVE SUNSCREEN82 g in 1 TUBELOTION/SHAMPOO825

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-050SPF30 SUPER SENSITIVE SUNSCREEN (TITANIUM DIOXIDE) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]5Current NDC, Legacy NDC, 5 package rows20241109_d79cf2d9-4923-452a-bb44-67e059ee37ee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
allantoinINACTIVE INGREDIENT344S277G0Z3
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YD3
candelilla waxINACTIVE INGREDIENTWL0328HX193
carthamus tinctorius seed oleosomesINACTIVE INGREDIENT9S60Q723093
coco-caprylateINACTIVE INGREDIENT4828G836N63
coconut oilINACTIVE INGREDIENTQ9L0O73W7L3
isoamyl laurateINACTIVE INGREDIENTM1SLX00M3M3
levulinic acidINACTIVE INGREDIENTRYX5QG61EI3
magnesium stearateINACTIVE INGREDIENT70097M6I303
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7U3
p-anisic acidINACTIVE INGREDIENT4SB6Y7DMM33
panthenolINACTIVE INGREDIENTWV9CM0O67Z3
polyglyceryl-2 dipolyhydroxystearateINACTIVE INGREDIENT9229XJ4V123
polyglyceryl-3 diisostearateINACTIVE INGREDIENT46P231IQV83
rosemaryINACTIVE INGREDIENTIJ67X351P93
squalaneINACTIVE INGREDIENTGW89575KF93
starch, riceINACTIVE INGREDIENT4DGK8B7I3S3
starch, tapiocaINACTIVE INGREDIENT24SC3U704I3
viola tricolorINACTIVE INGREDIENT9Q24RAI43V3
WaterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52915-05052915-050-29, 52915-050-18, 52915-050-06, 52915-050-19, 52915-050-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
panthenolWV9CM0O67ZIACT

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 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
levulinic acidLEVULINIC ACIDRYX5QG61EIFILM, EXTENDED RELEASE / TRANSDERMAL16.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
36 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
6 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii+route
36 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
24 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
starch, tapiocaSTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
6 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
starch, riceSTARCH, RICE4DGK8B7I3STABLET, EXTENDED RELEASE / ORAL301 mgExact identifier — unii candidate
6 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii+route
36 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
36 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii+route
36 equally ranked IID candidates
starch, riceSTARCH, RICE4DGK8B7I3STABLET, EXTENDED RELEASE / ORAL301 mgExact identifier — unii candidate
6 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii+route
36 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
24 equally ranked IID candidates
allantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
6 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii+route
36 equally ranked IID candidates
starch, tapiocaSTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
starch, tapiocaSTARCH, TAPIOCA24SC3U704ICAPSULE / ORAL100 mgExact identifier — unii candidate
12 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
levulinic acidLEVULINIC ACIDRYX5QG61EIFILM, EXTENDED RELEASE / TRANSDERMAL16.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii+route
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
24 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii+route
24 equally ranked IID candidates
squalaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii+route
36 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
36 equally ranked IID candidates
levulinic acidLEVULINIC ACIDRYX5QG61EISYSTEM / TRANSDERMAL20 mgExact identifier — unii candidate
12 equally ranked IID candidates
squalaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii+route
24 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii+route
36 equally ranked IID candidates
starch, riceSTARCH, RICE4DGK8B7I3STABLET, EXTENDED RELEASE / ORAL301 mgExact identifier — unii candidate
6 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
coconut oilCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii+route
24 equally ranked IID candidates
squalaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii+route
24 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route
36 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii+route
36 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii+route
36 equally ranked IID candidates
starch, riceSTARCH, RICE4DGK8B7I3STABLET, EXTENDED RELEASE / ORAL301 mgExact identifier — unii candidate
6 equally ranked IID candidates
starch, tapiocaSTARCH, TAPIOCA24SC3U704ICAPSULE / ORAL100 mgExact identifier — unii candidate
12 equally ranked IID candidates
starch, tapiocaSTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
medium-chain triglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route
36 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 BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
ndc (package): 52915-050-18
ndc (package): 52915-050-05
ndc (package): 52915-050-29
ndc (package): 52915-050-19
ndc (package): 52915-050-06
ndc (product): 52915-050
ndc11 (package): 52915005019
ndc11 (package): 52915005005
ndc11 (package): 52915005018
ndc11 (package): 52915005006
ndc11 (package): 52915005029
spl id: b50dbe26-9be4-43fe-9b77-638cb17964f4
spl set id: d79cf2d9-4923-452a-bb44-67e059ee37ee

Reported adverse events (FAERS/openFDA)#

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