ALLSWELL MINERAL SUNSCREEN SPF 30- zinc oxide lotion 
Stream2Sea, LLC

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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ALLSWELL MINERAL SUNSCREEN SPF 30

Active ingredient

Zinc Oxide 22%

Purpose

Sunscreen

Uses

Warnings

Directions

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic Capric Triglycerides, Butyrospermum Parkii (Shea) Butter, Beeswax, Helianthus Annus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Glyceryl Caprylate (and) Glyceryl Undecylenate, Non-GMO Corn Starch, Acrylates Copolymer, Vitamin E

Other Information

Questions or comments?

Allswell Mineral Sunscreen Spf 30-NDC 69555-043-01-Tube label

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ALLSWELL MINERAL SUNSCREEN SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69555-043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
STARCH, CORN (UNII: O8232NY3SJ)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69555-043-0151 in 1 TUBE; Type 0: Not a Combination Product03/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/28/2023
Labeler - Stream2Sea, LLC (052920828)
Establishment
NameAddressID/FEIBusiness Operations
Stream2Sea, LLC052920828manufacture(69555-043)

Revised: 4/2023
Document Id: f88fb3ff-ddc3-a2b3-e053-6394a90a8e6c
Set id: 03bee988-d6e3-4290-a926-9c5366649cba
Version: 1
Effective Time: 20230404
 
Stream2Sea, LLC