KAWAKIDS KAWASUN - PREMIUM MINERAL SUNSCREEN SPF 50- zinc oxide lotion

KawaKids KawaSun - Premium Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

KawaKids KawaSun - Premium Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by LCA COSMETICS LLC, Spencer Specialty Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide (Non-Nano) 25%

Purpose

Zinc Oxide (Non-Nano) 25%.............Sunscreen

Uses

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control Center immediately.

Directions

• Apply liberally to exposed areas 15 minutes before sun exposure
• Reapply:
• after 80 minutes of swimming or sweating
  • immediately after towel-drying
  • at least every two hours
  • 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 of 15 or higher and other protection measures including:
  • Limit time in the sun, especially from 10a.m.-2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Camellia Sinensis (Green Tea) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Caprylic/Capric Trigylceride (MCT Oil), Glycerin, Propanediol, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Cetyl Alcohol, Piper Excelsum (Kawakawa) Extract, Butyrospermum Parkii (Shea) Butter, Persea Americana (Avocado) Oil, Panthenol (Pro-Vitamin B-5), Tocopherol (Vitamin E) Acetate, Sargassum Fluitans/Natans Extract, Pentylene Glycol, PolyhydroxyStearic Acid, Benzyl Alcohol, Dehydroacetic Acid, Sclerotium Gum, Pullulan, Xanthan Gum, Sphingomonas Ferment Extract, Sodium Phytate.

Other Information

• Protect this product from excessive heat and direct sun
• Store at room temperature

Questions or comments?

1-657-789-5775

PRINCIPAL DISPLAY PANEL

Faith & Sage

Pharmacist Developed

Mom Approved

Premium Sunscreen Lotion

KawaKids

KawaSun

We believe in purity

Plant-derived Ingredients, Antioxidants, Vitamins E & B5, Zinc Oxide

Broad Spectrum SPF 50

Reef Safe & Water Resistant (80 Min.)

50 mL/1.75 fl oz

INGREDIENTS AND APPEARANCE

KAWAKIDS KAWASUN - PREMIUM MINERAL SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84569-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
CETYL ALCOHOL (UNII: 936JST6JCN)
PIPER EXCELSUM LEAF (UNII: 0258808825)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
PHYTATE SODIUM (UNII: 88496G1ERL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84569-123-50	50 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	08/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/09/2024

Labeler - LCA COSMETICS LLC (058943126)

Establishment
Name	Address	ID/FEI	Business Operations
Spencer Specialty Products, Inc		084478941	manufacture(84569-123)