BABIES KIDSSUN PROTECTION- mineral sunscreen powder

BABIES KIDSSUN PROTECTION by

Drug Labeling and Warnings

BABIES KIDSSUN PROTECTION by is a Otc medication manufactured, distributed, or labeled by PANERGYTEK USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium dioxide-19.5%

Zinc oxide-24%

PURPOSE

Sunscreen

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABIES KIDSSUN PROTECTION 
mineral sunscreen powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85950-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	240 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	195 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MICA (UNII: V8A1AW0880)
CI 77491 (UNII: 1K09F3G675)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
LOPHATHERUM GRACILE LEAF (UNII: R417138GE9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CI 77492 (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85950-001-01	5 g in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/20/2025

Labeler - PANERGYTEK USA INC (122142088)

Registrant - PANERGYTEK USA INC (122142088)