PEOPLE4OCEAN SPF30 SUNSCREEN- 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.

----------

People4Ocean SPF30 Sunscreen

Drug Facts

Active ingredient

Zinc oxide 22%

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 triglyceride, grape seed oil, beeswax, shea butter, candelilla wax, soybean oil, glyceryl isostearate, polyhydroxystearic acid, jojoba seed oil, tocopherol, safflower seed oil, english lavender oil, ylang ylang flower oil, patchouli leaf oil, vetiver root oil, geranium oil, cucumber fruit extract, carrot root extract, beta-carotene, rose hip fruit oil

Package Labeling:

Bottle

PEOPLE4OCEAN SPF30 SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73192-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION220 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
SOYBEAN OIL (UNII: 241ATL177A)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CANANGA OIL (UNII: 8YOY78GNNX)  
VETIVER OIL (UNII: 9M9P32M01L)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
CARROT (UNII: L56Z1JK48B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73192-010-02200 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2018
Labeler - P4O Distribution Pty Ltd (745079594)

Revised: 5/2020
Document Id: a5749b82-d845-2b03-e053-2995a90a3793
Set id: 96700ded-bccb-4d7a-a7ea-f4b4bcbc3879
Version: 2
Effective Time: 20200512
 
P4O Distribution Pty Ltd