MINERAL SUNSCREEN SPF30- zinc oxide spray

Mineral Sunscreen SPF30 by

Drug Labeling and Warnings

Mineral Sunscreen SPF30 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 14.0%

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

Flammable:

Do not use near heat, flame, or while smoking

When using this product

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 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 and avoid breathing mist
• Spray on hand and apply to face. Use in well-ventilated areas
• 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
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel use
• at least every 2 hours

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Glycerin, Caprylic/Capric Triglycerides, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Coco-Caprylate, Fragrance, Glyceryl Oleate Citrate, Methylheptyl Isostearate, Pentylene Glycol, Polyhydroxystearic Acid, Sodium Chloride, Sorbitan Oleate, Tocopheryl Acetate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF30 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	140 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CHAMOMILE (UNII: FGL3685T2X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-104-05	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	09/30/2023

Labeler - Hello Bello (081135707)