BABY MINERAL SUNSCREEN SPF55- zinc oxide lotion

Baby Mineral Sunscreen SPF55 by

Drug Labeling and Warnings

Baby Mineral Sunscreen 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

• Shake well before use
• 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:
  • Limiting time in the sun, especially from 10a.m. - 2p.m.
  • Wearing long-sleeved shirts, pants, hats and sunglasses

Other Information

• Protect this product from excessive heat and direct sun
• Avoid long-term exposure storage above 40°C (104°F)
• May stain some fabrics

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY MINERAL SUNSCREEN SPF55 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-100
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
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
ORANGE OIL (UNII: AKN3KSD11B)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)
VANILLA BEAN (UNII: Q74T35078H)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
COCOA BUTTER (UNII: 512OYT1CRR)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT OIL (UNII: Q9L0O73W7L)
CUCUMBER (UNII: YY7C30VXJT)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
AVOCADO (UNII: SDS87L369F)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SHEA BUTTER (UNII: K49155WL9Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-100-03	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)