FACIAL SUNSCREEN WITH ZINC SPF 50 DAYLOGIC- octinoxate 7.50% octisalate 5.00% oxybenzone 6.00% zinc oxide 7.00% cream

Facial Sunscreen with Zinc SPF 50 by

Drug Labeling and Warnings

Facial Sunscreen with Zinc SPF 50 by is a Otc medication manufactured, distributed, or labeled by Rite Aid, 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
Oxybenzone 6.0%...................................................................Sunscreen
Zinc Oxide 7.0%.......................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

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

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 before 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 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

OTHER SAFETY INFORMATION

Other information
protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Extract,
Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,
Cyclopentasiloxane, Cyclohexasiloxane, Diisopropyl Adipate, DMDM
Hydantoin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Glycerin, Hydrated
Silica, Hydrogenated Castor Oil, Polyethylene, Sodium Chloride,
Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,
Triethoxycaprylylsilane, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FACIAL SUNSCREEN WITH ZINC SPF 50  DAYLOGIC
octinoxate 7.50% octisalate 5.00% oxybenzone 6.00% zinc oxide 7.00% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1214
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
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Diisopropyl Adipate (UNII: P7E6YFV72X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
Ethylhexyl Palmitate (UNII: 2865993309)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Glycerin (UNII: PDC6A3C0OX)
Hydrated Silica (UNII: Y6O7T4G8P9)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
Sodium Chloride (UNII: 451W47IQ8X)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1214-1	28.3 g in 1 JAR; Type 0: Not a Combination Product	03/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/17/2017

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-1214) , label(11822-1214)