BABY MINERAL SUNSCREEN PROBIOTICS SPF55- zinc oxide lotion

Baby Mineral Sunscreen Probiotics SPF55 by

Drug Labeling and Warnings

Baby Mineral Sunscreen Probiotics SPF55 by is a Otc medication manufactured, distributed, or labeled by Hello Bello. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 20.0%

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

Do not use on

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

Directions

• Apply liberally and spread evenly by hand 15 minutes before sun exposure
• Reapply: after 80 minutes of swimming or sweating immediately after towel use at least every 2 hours
• For children under 6 months of age, ask a doctor
• 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 the product in this container from excessive heat and direct sun
• Avoid long-term exposure storage above 40°C (104°F)
• May stain some fabrics

Inactive Ingredients

Water (Aqua), Cocos Nucifera (Coconut) Oil*, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter*, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Arachidyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco Glucoside, Behenyl Alcohol, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyhydroxystearic Acid, Bisabolol*, Arachidyl Glucoside, Sodium Gluconate, Sodium Hyaluronate, Citric Acid, Triethyl Citrate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Vanilla Planifolia Fruit Extract, Prunus Armeniaca (Apricot) Kernel Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Avena Sativa (Oat) Kernel Oil, Bacillus Ferment, Persea Gratissima (Avocado) Fruit Extract*, Calendula Officinalis Flower Extract*, Cucumis Sativus (Cucumber) Fruit Extract*

*Organic

Questions?

(888)860-6888

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY MINERAL SUNSCREEN PROBIOTICS SPF55 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-101
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
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
COCO GLUCOSIDE (UNII: ICS790225B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
COCOA BUTTER (UNII: 512OYT1CRR)
VANILLA (UNII: Q74T35078H)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE OIL (UNII: AKN3KSD11B)
COCONUT OIL (UNII: Q9L0O73W7L)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
AVOCADO (UNII: SDS87L369F)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
CUCUMBER (UNII: YY7C30VXJT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-101-03	85.05 g in 1 TUBE; Type 0: Not a Combination Product	07/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	07/28/2023

Labeler - Hello Bello (081135707)