DeVita Solar Protect SPF 30 with Aloe-Hyplex

Solar Protect by

Drug Labeling and Warnings

Solar Protect by is a Otc medication manufactured, distributed, or labeled by Velocity Production & Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOLAR PROTECT SPF 30- zinc oxide lotion 
Velocity Production & Packaging, LLC

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 Solar Protect SPF 30 with Aloe-Hyplex

Active Ingredient

Active Ingredient

Zinc Oxide 22.75%

Purpose

Purpose

Sunscreen

Uses

Uses

* Helps prevent sunburn

* Offers full spectrum UVA/UVB sun protection

* 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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

* Shake well before use.

* 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

Other Information

Other information:

Titanium Dioxide free

Inactive Ingredients

Inactive Ingredients

Aloe Barbadensis Leaf Juice*, Coco-Caprylate/Caprate, Propanediol, Isoamyl Cocoate, Glycerin, Shea Butter Ethyl Esters, Galactoarabinan, Brassica Oleracea Italica (Broccoli) Seed Oil, Sodium Olivoyl Glutamate, Glyceryl Stearate, Cetearyl Alcohol, Polyglyceryl-3 Polyricinoleate, Plukenetia Volubilis Seed Oil, Caprylic/Capric Triglyceride, Sodium Hyaluronate, Cannabis Sativa Seed Oil, Apium Graveolens (Celery) Callus Extract, Camellia Sinensis Leaf Extract, Tocopherol, Linoleic Acid, Linolenic Acid, Vitis Vinifera (Grape) Seed Oil, Prunus Domestica Seed Oil, Allantoin, Stearic Acid, Isostearic Acid, Glyceryl Caprylate, Xanthan Gum, Caprylhydroxamic Acid, Ethylhexylglycerin, Potassium Sorbate

NDC: 72591-7889-5 60 g (50 mL) outer carton

NDC: 72591-7889-5 60 g (50 mL) bottle

SOLAR PROTECT  SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72591-7889
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
BROCCOLI SEED OIL (UNII: SY01LVD4G4)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
ISOAMYL COCOATE (UNII: 14OG46E98E)
ISOSTEARIC ACID (UNII: X33R8U0062)
LINOLENIC ACID (UNII: 0RBV727H71)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
PLUM SEED OIL (UNII: 67EIU8N086)
GRAPE SEED OIL (UNII: 930MLC8XGG)
XANTHAN GUM (UNII: TTV12P4NEE)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
GALACTOARABINAN (UNII: SL4SX1O487)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72591-7889-5	1 in 1 CARTON	07/07/2020	09/30/2020
1		60 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2020	09/30/2020

Labeler - Velocity Production & Packaging, LLC (081076893)

Establishment
Name	Address	ID/FEI	Business Operations
Velocity Production & Packaging, LLC		081076893	manufacture(72591-7889)

Revised: 12/2021

Document Id: d30e0735-cbfa-2b83-e053-2995a90a1da4

34390-5

Set id: a9e16d22-c33c-3f56-e053-2a95a90ad2b2

Version: 2

Effective Time: 20211213