DEVITA NATURAL SKIN CARE SOLAR PROTECTIVE MOISTURIZER BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN- zinc oxide cream
Devita International Inc

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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Devita Natural Skin Care Solar Protective Moisturizer Broad Spectrum SPF 30 Mineral Sunscreen

Drug Facts

Active Ingredient

Micronized Zinc Oxide 19%

Purpose

Sunscreen

Uses

Offers full spectrum UVA/UVB sun protection
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 ecternal 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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply every 90 minutes and immediately after swimming, sweating or towel drying
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 skin 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

Aloe barbadensis* (aloe vera) gel, Purified water (aqua), Capric/Caprylic triglycerides (derived from coconut oil), Glycerin (vegetable), Hyaluronic acid (vegan source), Glyceryl stearate SE (derived from vegetable oil), Stearic acid, Lecithin phospholipid, Tocopherol (vitamin E), Allantoin, Vitis vinifera* (grape) seed extract

Other Information

Titanium Dioxide free and reef friendly

Questions or comments?

1-877-2-DEVITA • www.devitaskincare.com Manufactured for DeVita Int'l., Inc. Phoenix, AZ

Package Labeling:

label1

DEVITA NATURAL SKIN CARE SOLAR PROTECTIVE MOISTURIZER BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70123-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	190 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
ALLANTOIN (UNII: 344S277G0Z)
VITIS VINIFERA SEED (UNII: C34U15ICXA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70123-101-75	1 in 1 CARTON	11/17/2015	05/01/2019
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/17/2015	05/01/2019

Labeler - Devita International Inc (106907483)

Revised: 8/2017

Document Id: 56e04db0-a4e7-322b-e054-00144ff88e88

Set id: 5c5fa988-4e08-425b-b791-cd7ff4967735

Version: 3

Effective Time: 20170816

Devita International Inc