Otc - Active Ingredient
Titanium dioxide-19.5%
Zinc oxide-24%
Babies Kidssun Protection Powder
FDA Label NDC 85950-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Panergytek Usa Inc for the product Babies Kidssun Protection (NDC 85950-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - When Using
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
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
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
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
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
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
85950-001-01 (85950 001 01)
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