PEOPLE4OCEAN SPF30 SUNSCREEN- zinc oxide cream

People4Ocean SPF30 Sunscreen by

Drug Labeling and Warnings

People4Ocean SPF30 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%

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

• for sunscreen use
• apply generously 15 minutes before sun exposure
• 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

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

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:

INGREDIENTS AND APPEARANCE

PEOPLE4OCEAN SPF30 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73192-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
BETA CAROTENE (UNII: 01YAE03M7J)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73192-010-02	200 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2018

Labeler - P4O Distribution Pty Ltd (745079594)