UltrasolSunscreen

Manufacturer
Fischer Pharmaceuticals Ltd.
Effective date
2010-03-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:12

Label at a glance#

ProductUltrasolSunscreen KIDS Sunscreen Mousse
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 40C (104F)

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, Dicaprylyl Ether, Disodium EDTA, Ethylparaben,
Fragrance, Glycerin, Iodopropynyl Butylcarbamate, 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

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

24m

NO CFCs

NO ANIMAL INGREDIENTS NO ANIMAL TESTING

Dr. Fischer - Tried and Tested

PDP and BackPDP and Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59886-316-662020-01-31C16284748780-19d75b9d1-0075-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL KIDS Sunscreen Mousse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-316-66UltrasolSunscreenKIDS Sunscreen Mousse200 g in 1 CANAEROSOL, FOAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-316ULTRASOLSUNSCREEN KIDS SUNSCREEN MOUSSE (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, FOAM [FISCHER PHARMACEUTICALS LTD.]2Legacy NDC, 1 package rows20100410_9a8a932e-c3dc-44ae-91e6-b9e3f5b21ee3.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
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
EthylparabenINACTIVE INGREDIENT14255EXE392
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
IsobutaneINACTIVE INGREDIENTBXR49TP6112
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
PanthenolINACTIVE INGREDIENTWV9CM0O67Z2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
PropaneINACTIVE INGREDIENTT75W9911L62
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD562

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59886-31659886-316-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED / ORAL12 mgExact identifier — unii candidate
16 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CREAM / TOPICAL11000 mgExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56GEL / TOPICAL20 mgExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56LOTION / TOPICAL7 mgExact identifier — unii candidate
16 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SPRAY / TOPICAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 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
52182e84-280a-41db-b234-fc974b30a8f39a8a932e-c3dc-44ae-91e6-b9e3f5b21ee32010-03-25WarningsExact identifier
spl id: 52182e84-280a-41db-b234-fc974b30a8f3
spl set id: 9a8a932e-c3dc-44ae-91e6-b9e3f5b21ee3

Reported adverse events (FAERS/openFDA)#

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