MINERAL SUNSCREEN SPF30- zinc oxide spray 
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mineral Sunscreen Spray SPF30

Drug Facts

Active Ingredients

Zinc Oxide 14.0%

Purpose

Sunscreen

Uses

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

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

SPF 30 Continuous Spray 5oz

MINERAL SUNSCREEN SPF30 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE140 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73418-104-05142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/30/2023
Labeler - Hello Bello (081135707)

Revised: 9/2023
Document Id: 01cc4ea0-e3e1-32f1-e063-6394a90a1375
Set id: 01cc4ea0-e3e0-32f1-e063-6394a90a1375
Version: 1
Effective Time: 20230930
 
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