YOU-V SPF-30 BROAD SPECTRUM SUNSCREEN- titanium dioxide, zinc oxide lotion

YOU-V SPF-30 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

YOU-V SPF-30 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by YouV, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 6.00%

Zinc Oxide 3.50%

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:

Do not shine light directly into eyes. 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 consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediatly.

Directions:

• Apply liberally 15 minutes before sun exposure.
• Use light to reveal where sunscreen is applied.
• For best results, use light indoors or in shade.

Reapply: At least every two-hours 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

• Limit time in the sun, especially between 10am and 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6-months, consult a physician.

Other ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Hydroxide, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beeswax, Bis(glycidoxyphenyl) Propane/Aminomethyl Norbornane Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carica Papaya Fruit Extract, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethyl Vanillin, Ethylhexylglycerin, Flourescent Brightener 230, Glycerin, Glyceryl Stearate, Helianthu Annuus (Sunflower) Oil, Laminaria (Algae) Extract, Linoleic Acid, Olea Europaca (Olive) Oil, Phenoxyethanol, Polysorbate-20, Rubus Idaeus (Raspberry) Extract, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E)

Other Information:

Protect this product from excessive heat & direct sunlight

Questions?

Visit: youvsunscreen.com Manufactured by YouV LLC

Package Labeling:

INGREDIENTS AND APPEARANCE

YOU-V SPF-30 BROAD SPECTRUM SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73243-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL VANILLIN (UNII: YC9ST449YJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
GREEN OLIVE (UNII: 6HD2W46UEG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
RASPBERRY (UNII: 4N14V5R27W)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73243-045-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	07/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/22/2019

Labeler - YouV, LLC (117082836)