SUN SHIELD SPF 50- zinc oxide and titanium dioxide cream

Sun Shield SPF 50 by

Drug Labeling and Warnings

Sun Shield SPF 50 by is a Otc medication manufactured, distributed, or labeled by ALLURE LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide - 8.6%

Titanium Dioxide - 6.5%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

Keep out of eyes. Rinse with water to remove.

STOP USE

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.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes prior to 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in sun sun, especially from 10 am - 2 pm.
• wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Water (Aqua), Cyclopenatasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Alminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Glycerin, Sodium Chloride, Polyglyceryl-4 Isostearate, Vitis Vinifera, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetearyl Olivate, Sorbitan Olivate, Cyclohexasiloxane, Tocopherol, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Dimethicone/Polyglycerin-3 Crosspolymer, Isomalt, Dimethicone / Vinyl Dimethicone Crosspolymer Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Ascorbic Acid, Ascorbyl Palmitate, Citric Acid, Sodium Benzoate.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

Call toll free 1-800 830-1491 in the USA.

info@atzen.com

PRINCIPAL DISPLAY PANEL

Toll free in USA: 800.830.1491

Email: info@atzen.com

www.atzen.com

Developed in France. Made in USA.

INGREDIENTS AND APPEARANCE

SUN SHIELD SPF 50 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	86 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
VITIS VINIFERA FRUIT RIND (UNII: 653OHN32Q1)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4161-2	1 in 1 CARTON	12/15/2017
1	NDC: 62742-4161-1	90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/11/2017

Labeler - ALLURE LABS INC (926831603)