ORGANIC MATTERS SPF 50 SUNSCREEN- zinc oxide cream

Organic Matters SPF 50 Sunscreen by

Drug Labeling and Warnings

Organic Matters SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Veganic SKN Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc oxide 25%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Please kindly refer to artwork

WARNINGS

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KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

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INACTIVE INGREDIENT

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORGANIC MATTERS SPF 50 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
CORIANDER OIL (UNII: 7626GC95E5)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM ASCORBATE (UNII: S033EH8359)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
JOJOBA OIL (UNII: 724GKU717M)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GRAPEFRUIT OIL (UNII: YR377U58W9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-046-00	0.11 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/26/2024

Labeler - Veganic SKN Limited (743536682)

Registrant - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	manufacture(83252-046) , pack(83252-046) , label(83252-046)