PEOPLE4OCEAN SPF50 SUNSCREEN VEGAN- zinc oxide cream 
P4O Distribution Pty Ltd

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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People4Ocean SPF50 sunscreen vegan

Drug Facts

Active ingredient

Zinc oxide 22.5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

  • on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

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

Other information

Inactive ingredients

caprylic/capric triglycerideº, castor oilº, candelilla wax*, coco-caprylate/caprateº, coconut oilº, tocopherol acetateº, polyglyceryl-3 polyricinoleateº, lavender oil*, ylang ylang flower oil*, patchouli leaf oil*, vetiver root oil*, geranium oil*, isostearic acidº. ºOrganic |*Natural.

Package Labeling:

Label

PEOPLE4OCEAN SPF50 SUNSCREEN VEGAN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73192-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION225 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CASTOR OIL (UNII: D5340Y2I9G)  
CANDELILLA WAX (UNII: WL0328HX19)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CANANGA OIL (UNII: 8YOY78GNNX)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73192-020-00100 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2019
Labeler - P4O Distribution Pty Ltd (745079594)

Revised: 7/2020
Document Id: a95e19d7-6af5-2870-e053-2995a90ae4ac
Set id: 5a50e767-898f-414d-90a2-a4b56799efcc
Version: 1
Effective Time: 20200701
 
P4O Distribution Pty Ltd