ULTRASOL

Manufacturer
Fischer Pharmaceuticals Ltd.
Effective date
2010-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:46

Label at a glance#

ProductULTRASOL KIDS
Active ingredientAvobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Label structure8 sections

Indications and uses

• helps prevent sunburn • higher SPF gives more sunburn protection • helps protect the skin against the harmful effects of UVA and UVB rays • retains SPF after 80 minutes of activity in the water or sweating

Dosage and administration

• apply generously and evenly to all exposed areas before sun exposure • reapply as needed or after towel drying, swimming, perspiring or vigorous activity • children under 6 months of age: ask a doctor • do not spray directly on face. Spray into hands and apply to face • use in well-ventilated areas

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                                                 Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%,
Octocrylene 9.0%, Oxybenzone 4.0% ................................................ Sunscreen

Uses

OTC - PURPOSE SECTION

• helps prevent sunburn • higher SPF gives more sunburn protection
• helps protect the skin against the harmful effects of UVA and UVB rays
• retains SPF after 80 minutes of activity in the water or sweating

Warnings

WARNINGS SECTION

For external use only

Flammable:

SAFE HANDLING WARNING SECTION

Do not use near heat, flame, or while smoking. Avoid long term
storage above 40˚C (104˚F)

When using this product

OTC - WHEN USING SECTION

• avoid contact with the eyes. If contact occurs rinse
thoroughly with water • do not puncture or incinerate. Contents under pressure.
Do not store at temperatures above 120°F

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison
Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply generously and evenly to all exposed areas before sun exposure
• reapply as needed or after towel drying, swimming, perspiring or vigorous activity
• children under 6 months of age: ask a doctor • do not spray directly on face. Spray
into hands and apply to face • use in well-ventilated areas

Other Information

SPL UNCLASSIFIED SECTION

• may stain some fabrics • Sun alert: Limiting sun
exposure, wearing protective clothing, and using sunscreens may reduce the risks of
skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Aminomethyl Propanol, Butylparaben, Camellia Sinensis Leaf Extract, Cetyl Dimethicone,
Chamomilla Recutita (Matricaria) Extract, Chlorphenesin, Dicaprylyl Ether, Disodium
EDTA, Ethylparaben, Fragrance, Glycerin, Isobutylparaben, Menthyl Lactate, Methylparaben,
Panthenol, Phenoxyethanol, Potassium Cetyl Phosphate, Propane/Butane/Isobutane,
Propylparaben, Sorbitane Oleate, Tocopheryl Acetate, VP/Eicosene Copolymer, Water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-212-1985 Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Fischer

ULTRASOL

KIDS Sunscreen Mousse SPF30

Broad Spectrum UVA and UVB Protection

Dermatologist Recommended

Fun Melon Fragrance

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Hypoallergenic

200 ML. 6.77 FL. OZ.

FISCHER PHARMACEUTICALS

NO ANIMAL INGREDIENTS NO ANIMAL TESTING

24M

NO CFCs

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

Dr. Fischer - Tried and Tested


PDP and BackPDP and Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59886-353-662020-01-31C16284748780-19d75b9d0-8938-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL SPF30 KIDS Sunscreen Mousse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-353-66ULTRASOLKIDS200 g in 1 CANAEROSOL, FOAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-353ULTRASOL KIDS (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2Legacy NDC, 1 package rows20100610_7d10e92a-1f9c-4ba9-8c56-7716eb53999b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX2
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OctisalateACTIVE INGREDIENT4X49Y0596W2
OctocryleneACTIVE INGREDIENT5A68WGF6WM2
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y2
AvobenzoneACTIVE MOIETYG63QQF2NOX2
OctinoxateACTIVE MOIETY4Y5P7MUD512
OctisalateACTIVE MOIETY4X49Y0596W2
OctocryleneACTIVE MOIETY5A68WGF6WM2
OxybenzoneACTIVE MOIETY95OOS7VE0Y2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ButaneINACTIVE INGREDIENT6LV4FOR43R2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV82
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
EthylparabenINACTIVE INGREDIENT14255EXE392
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
IsobutaneINACTIVE INGREDIENTBXR49TP6112
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
PanthenolINACTIVE INGREDIENTWV9CM0O67Z2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
PropaneINACTIVE INGREDIENTT75W9911L62
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD562
WaterINACTIVE INGREDIENT059QF0KO0R2

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
59886-35359886-353-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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 6 · 352 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PropylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHFILM, SOLUBLE / BUCCAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
ButaneBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
IsobutaneISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii candidate
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56LOTION / TOPICAL7 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SOLUTION / ORAL1080 mgExact identifier — unii candidate
16 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ButaneBUTANE6LV4FOR43RAEROSOL, FOAM / RECTAL12 mgExact identifier — unii candidate
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
4 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 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
1a362e48-3a54-4443-97eb-5e996e9202237d10e92a-1f9c-4ba9-8c56-7716eb53999b2010-05-06WarningsExact identifier
spl id: 1a362e48-3a54-4443-97eb-5e996e920223
spl set id: 7d10e92a-1f9c-4ba9-8c56-7716eb53999b

Reported adverse events (FAERS/openFDA)#

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