Vivaoidays Sunscreen With Turmeric (Zinc Oxide) Lotion [5 Senco Inc.] -

VIVAOIDAYS SUNSCREEN WITH TURMERIC (ZINC OXIDE) LOTION [5 SENCO INC.]
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NDC	71778-001-01
Set ID	4b716a6d-5f88-44bf-865c-a2fd06de0e13
Category	HUMAN OTC DRUG LABEL
Packager	5 SENCO Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Zinc Oxide 20%
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 40 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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Inactive ingredients

SIMMONDSIA CHINENSIS (JOJOBA)SEED OIL 1, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL 1, CAPRYLIC/CAPRIC TRIGLYCERIDE, BUTYROSPERMUM PARKII (SHEA) BUTTER 1, CERA ALBA/BEESWAX 1, HYDROGENATED VEGETABLE OIL, GLYCERYL STEARATE, OLEA EUROPAEA (OLIVE) FRUIT OIL 1, PARFUM, POLYHYDROXYSTEARIC ACID, HIPPOPHAE RHAMNOIDES (SEABUCKTHORN) FRUIT OIL 1, TOCOPHEROL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT 1, CALENDULA OFFICINALIS (CALENDULA) FLOWER EXTRACT 1.

1

From organic farming.
Other information
- protect the product from excessive heat and direct sun
Questions or comments?

To report serious adverse event, call 310-453-0137 or email: Support@vivaiodays.com
PRINCIPAL DISPLAY PANEL - 100 ml Tube Label

VIVAIODAYS

Organic World Secrets for baby & kid

SUNSCREEN
WITH TURMERIC

inspired by Borneo

30
BROAD SPECTRUM SPF 30

NON-NANO
ZINC OXIDE
WATER RESISTANT
40 Minutes
EASY TO APPLY

• MADE WITH 59.14% ORGANIC INGREDIENTS
COSMOS
ORGANIC

100ml / 3.4 fl.oz

INGREDIENTS AND APPEARANCE

VIVAIODAYS SUNSCREEN WITH TURMERIC
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71778-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)
SHEA BUTTER (UNII: K49155WL9Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
TURMERIC (UNII: 856YO1Z64F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71778-001-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/15/2018

Labeler - 5 SENCO Inc. (055882668)

Name	Address	ID/FEI	Business Operations
Establishment
Stasinos Sikalias		363281305	manufacture(71778-001)

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Medic

VIVAOIDAYS SUNSCREEN WITH TURMERIC (ZINC OXIDE) LOTION [5 SENCO INC.]

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