CREAL ZINK SUNSCREEN SPF 50 WELL AT WALGREENS- octinoxate 7.5% octisalate 5.0% zinc oxide 14.5% stick 
Walgreens

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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Drug Facts

Active ingredients                                                                            Purpose
Octinoxate 7.5%                                                                               Sunscreen
Octisalate 5.0%                                                                                 Sunscreen
Zinc Oxide 14.5%                                                                              Sunscreen

Uses • helps prevent sunburn

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to
remove. • Keep away from face to avoid breathing it • Do not puncture or
incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
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
• spray liberally and spread evenly by hand 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions • use in a well-ventilated area
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

Aloe Barbadensis Leaf Extract
Ascorbic Acid
C12-15 Alkyl Benzoate
Camellia Sinensis Leaf Extract
Copernicia Cerifera (Carnauba) Wax
Dimethicone
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Microcrystalline Wax
Hydrogenated Polyisobutene
Octyldodecanol
Paraffin
PEG-8 Dimethicone
Polyethylene
Retinyl Palmitate
Silica
Sodium Propoxyhydroxypropyl Thiosulfate Silica
Synthetic Wax
Tocopheryl Acetate
Triethoxycaprylylsilane

image descriptionimage description

CREAL ZINK SUNSCREEN SPF 50  WELL AT WALGREENS
octinoxate 7.5% octisalate 5.0% zinc oxide 14.5% stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Dimethicone (UNII: 92RU3N3Y1O)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Octyldodecanol (UNII: 461N1O614Y)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PEG-8 Dimethicone (UNII: GIA7T764OD)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1117-0114 g in 1 TUBE; Type 0: Not a Combination Product12/07/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/07/2015
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-1117) , label(0363-1117)

Revised: 2/2018
Document Id: 798f3288-ddfc-48d5-b0b7-5ce173a88d3e
Set id: 2b16a380-9b92-463d-a204-a048e1b0d9c8
Version: 2
Effective Time: 20180220
 
Walgreens