PEOPLE4OCEAN SPF50 SUNSCREEN- zinc oxide lotion

People4Ocean SPF50 sunscreen by

Drug Labeling and Warnings

People4Ocean SPF50 sunscreen by is a Otc medication manufactured, distributed, or labeled by P4O Distribution Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc oxide 22.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

• apply liberally and evenly 15 minutes before sun exposure
• Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours.
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Other information

• store below 86°F (30°C)
• protect the product in this container from excessive heat and direct sun

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:

INGREDIENTS AND APPEARANCE

PEOPLE4OCEAN SPF50 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73192-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	225 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73192-030-00	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2019

Labeler - P4O Distribution Pty Ltd (745079594)