OTC Medication Information: People4Ocean SPF50 Sunscreen Vegan

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.

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 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

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
(click image for full-size original)

PEOPLE4OCEAN SPF50 SUNSCREEN VEGAN
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73192-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 225 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
CASTOR OIL
CANDELILLA WAX
COCOYL CAPRYLOCAPRATE
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
POLYGLYCERYL-3 PENTARICINOLEATE
LAVENDER OIL
CANANGA OIL
GERANIUM OIL, ALGERIAN TYPE
ISOSTEARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73192-020-00 100 mL in 1 TUBE None
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)

Revised: 07/2020 P4O Distribution Pty Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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