Dr. Fischer ULTRASOL nature BABY Sunscreen Face Cream SPF 45

Manufacturer
Fischer Pharmaceuticals Ltd
Effective date
2010-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:45

Label at a glance#

ProductUltrasolSunscreen nature BABY Sunscreen Face Cream SPF 45
Active ingredientAvobenzone, Octinoxate, Octisalate, 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

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


PDP and BackPDP and Back


Image of box
Image of box

Dr Fischer ULTRASOL

nature BABY

Sunscreen SPF 45

Face Cream

Broad Spectrum

UVA and UVB Protection

Pediatrician Recommended

With Oatmeal and Aloe Vera

SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

VERY WATER RESISTANT

Ophthalmologically Tested

Non-Irritating

RECOMMENDED - SKIN CANCER FOUNDATION

50 ML. 1.69 FL. OZ.

(Back of the package):

Manufactured by:

Fischer Pharmaceuticals Ltd.

Bnei Brak, Israel, 51553

Made in Israel

www.dr-fischer.com

NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

24m

FISCHER PHARMACEUTICALS

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                                                                 Purpose
Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%,
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

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes. If contact occurs rinse
thoroughly with water.

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

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, Aloe
Barbadensis (Aloe Vera) Leaf Extract, Avena Sativa (Oat) Kernel Extract,
Butylparaben, Calendula officinalis Flower Oil, Chamomilla Recutita (Matricaria)
Extract, Chlorophenesin, Disodium EDTA, Ethylparaben, Fragrance, Glyceryl
Stearate, Green Tea (Camellia Sinensis) Leaf Extract, Iodopropynyl
Butylcarbamate, Isopropyl Myristate, Methylparaben, Phenoxyethanol,
Polyethylene, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben,
Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate, Water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-212-1985 Mon-Fri

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59886-337-772020-01-31C16284748780-19d75b9d0-a930-f424-e053-dadaa90a57ceDr. Fischer ULTRASOL nature BABY Sunscreen Face Cream SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59886-337-77UltrasolSunscreennature BABY Sunscreen Face Cream SPF 4550 g in 1 TUBECREAM501
59886-337-77UltrasolSunscreennature BABY Sunscreen Face Cream SPF 451 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59886-337ULTRASOLSUNSCREEN NATURE BABY SUNSCREEN FACE CREAM SPF 45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]1Legacy NDC, 2 package rows20100301_70b65f42-f22c-42dc-94da-d174daf2016a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ButylparabenINACTIVE INGREDIENT3QPI1U3FV81
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
EthylparabenINACTIVE INGREDIENT14255EXE391
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJS1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1Y1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59886-33759886-337-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 10 · 584 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHJELLY / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
Stearyl AlcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii candidate
12 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSFILM / TRANSDERMAL58.08 mgExact identifier — unii candidate
18 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Isopropyl MyristateISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
Stearyl AlcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / VAGINAL425 mgExact identifier — unii candidate
12 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact 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
1816044f-baee-4357-b24b-b2cf57b282a370b65f42-f22c-42dc-94da-d174daf2016a2010-01-26WarningsExact identifier
spl id: 1816044f-baee-4357-b24b-b2cf57b282a3
spl set id: 70b65f42-f22c-42dc-94da-d174daf2016a

Reported adverse events (FAERS/openFDA)#

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