KIDS MINERAL SUNSCREEN SPF50- sunscreen spray

Kids Mineral Sunscreen SPF50 by

Drug Labeling and Warnings

Kids Mineral Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Hello Bello, Bell International Laboratories, Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 16%

Purpose

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

Flammable: Do not use near heat, flame, or while smoking

Do not use on

broken or damaged skin

When using this product

Keep away from face and avoid breathing it. Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Shake well before use
• Apply liberally and spread evenly by hand 15 minutes before sun exposure
• Hold 4 to 6 inches away from body when spraying
• For children under 6 months of age, ask a doctor
• Do not spray directly on face
• Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions.
• Reapply: after 80 minutes of swimming or sweating immediately after towel use at least every 2 hours
• Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m. - 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

• Protect this product from excessive heat and direct sun
• May stain some fabrics

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Isononyl Isnonanoate, Dicaprylyl Carbonate, Methyl Dihydroabietate, Propanediol, Isocetyl Stearoyl Stearate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Polyester-8, C18-21 Alkane, Silica, Alumina, Tocopherol, Bisabolol, Polyhydroxystearic Acid, Coco-Glucoside, Glycerin, Caprylyl Glycol, Caprylhydroxamic Acid, Musa Sapientum (Banana) Fruit Extract, Sodium Gluconate, Citric Acid, Aloe Barbadensis Leaf Juice, Bentonite, Microcrystalline Cellulose, Cellulose Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS MINERAL SUNSCREEN SPF50 
sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
C18-C21 ALKANE (UNII: 33822S0M40)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LEVOMENOL (UNII: 24WE03BX2T)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
COCO GLUCOSIDE (UNII: ICS790225B)
BANANA (UNII: 4AJZ4765R9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-105-05	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	09/13/2023

Labeler - Hello Bello (081135707)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories, Incorporated		967781555	manufacture(73418-105)