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

Creal Zink Sunscreen SPF 50 by

Drug Labeling and Warnings

Creal Zink Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1117-01	14 g in 1 TUBE; Type 0: Not a Combination Product	12/07/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/07/2015

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-1117) , label(0363-1117)