Sunscreen by NATURAL AND ORGANIC FORMULATIONS (PTY) LTD

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by NATURAL AND ORGANIC FORMULATIONS (PTY) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN- sunscreen, zinc oxide lotion 
NATURAL AND ORGANIC FORMULATIONS (PTY) LTD

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30mL Sunscreen label Principal Display Panel

SUNSCREEN 
sunscreen, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83748-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ZINC SULFATE (UNII: 89DS0H96TB)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JOJOBA OIL (UNII: 724GKU717M)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GLYCERYL OLEATE (UNII: 4PC054V79P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SHEA BUTTER (UNII: K49155WL9Y)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83748-001-01	1 in 1 CARTON	12/13/2023
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/13/2023	12/13/2023

Labeler - NATURAL AND ORGANIC FORMULATIONS (PTY) LTD (598865809)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL AND ORGANIC FORMULATIONS (PTY) LTD		598865809	manufacture(83748-001)

Revised: 6/2024

Document Id: 1be24959-0ace-e4c6-e063-6294a90a4378

34390-5

Set id: 07654845-3108-8811-e063-6294a90a80f0

Version: 2

Effective Time: 20240627

 

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