BABIES KIDSSUN PROTECTION - PANERGYTEK USA INC

Manufacturer
PANERGYTEK USA INC
Effective date
2026-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:34:39

Label at a glance#

ProductBABIES KIDSSUN PROTECTION
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide-19.5%

Zinc oxide-24%

OTC - PURPOSE SECTION

Sunscreen

OTC - WHEN USING SECTION

Helps prevent sunburn.If used as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun.

WARNINGS SECTION

For external use only.Do not use on damaged or broken skinWhen using this product keep out ofeyes. Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. lfproducts swallowed. get medical helpor contact a Poison Control Center rightaway.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sunexposure.
Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sunexposure.
Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

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.

OTHER SAFETY INFORMATION

Protect this product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Vinyl Dimethicone/MethiconeSilsesquioxane Crosspolymer.

Aluminum hydroxide.

LavandulaAngustifolia (Lavender) Oil,

Mica.

Lophatherum Gracile Leaf Power,

Dimethicone,

Triethoxycoprylylsilane

.Stearic Acid,

Tocopherol(Vitamin E),

C1 77492,

C1 77491

Sodium Benzoate

,Potassium Sorbate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85950-001-0185950-001-01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.bellasfriends.com/contactus85950-001-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85950-00185950-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-08-01full-release2026-06-01 01:09:09

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
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
ndc (package): 85950-001-01
ndc (product): 85950-001
ndc11 (package): 85950000101
spl id: 54b0ce49-02c3-1203-e063-6394a90aa80a
spl set id: 3a554118-b71d-a844-e063-6294a90a699f

Reported adverse events (FAERS/openFDA)#

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