PEOPLE4OCEAN SPF50 SUNSCREEN- zinc oxide lotion 
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

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

Purified water, Coco-Caprylate/Caprate, Caprilic/capric triglycerideº, Polyglyceryl-3 Polyricinoleate, Dimethicone, Octyl Palmitate, Isostearic Acidº, Butylene glycol, PEG-30 dipolyhydroxystearate, Beeswaxº, Glycerol, Polyethylene, Phenoxyethanol, Glyceryl oleate, Ethylhexylglycerin, Lavender Oil*, Ylang Ylang Flower Oil*, Patchouli Leaf Oil*, Vetiver Root Oil*, Geranium Oil*, Xanthan gum. ºOrganic | *Natural.

Package Labeling:

Label2

PEOPLE4OCEAN SPF50 SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73192-030
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
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CANANGA OIL (UNII: 8YOY78GNNX)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73192-030-001000 mL in 1 BOTTLE, PUMP; 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: a95e19d7-6ae6-2870-e053-2995a90ae4ac
Set id: d21fb067-35c0-411c-828a-344ec4a84bb6
Version: 1
Effective Time: 20200701
 
P4O Distribution Pty Ltd