HIYA KIDS SPF 40 MINERAL SUNSCREN- zinc oxide paste

Hiya Kids SPF 40 Mineral Sunscren by

Drug Labeling and Warnings

Hiya Kids SPF 40 Mineral Sunscren by is a Otc medication manufactured, distributed, or labeled by Hiya Health Products LLC, Stream2Sea, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Ceenter immediately.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

For children under 6 months of age: ask a doctor.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Cera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.

Hiya Kids Mineral Sunscreen Package Label

INGREDIENTS AND APPEARANCE

HIYA KIDS SPF 40 MINERAL SUNSCREN 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85447-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
BEESWAX (UNII: 2ZA36H0S2V)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON BALM OIL (UNII: MJ76269K9S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MICA (UNII: V8A1AW0880)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
SILICA (UNII: ETJ7Z6XBU4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85447-001-01	65 g in 1 CANISTER; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2025

Labeler - Hiya Health Products LLC (119071051)

Registrant - Hiya Health Products LLC (119071051)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea, LLC		052920828	manufacture(85447-001)