BABIES KIDSSUN PROTECTION
3a554118-b71d-a844-e063-6294a90a699f
HUMAN OTC DRUG LABEL
Aug 1, 2025
PANERGYTEK USA INC
DUNS: 122142088
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MINERAL SUNSCREEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 - 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.
OTC - ACTIVE INGREDIENT SECTION
Titanium dioxide-19.5%
Zinc oxide-24%
OTC - PURPOSE SECTION
Sunscreen
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
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