SUNSCREEN SPF 30 DAYLOGIC- avobenzone 2.00% homosalate 10.50% octisalate 5.00% octocrylene 2.00% oxybenzone 2.00% lotion

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 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
Avobenzone 2.00%...............................................................Sunscreen
Homosalate 10.50%..............................................................Sunscreen
Octisalate 5.00%...................................................................Sunscreen
Octocrylene 2.00%................................................................Sunscreen
Oxybenzone 2.00%...............................................................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. If product is swallowed, get medicalhelp 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

Inactive ingredients

Aloe Barbadensis Leaf Juice
Barium Sulfate
Benzyl Alcohol
Carbomer
Cocos Nucifera (Coconut) Oil
Dimethicone
Disodium EDTA
Fragrance
Methylparaben
Mineral Oil
Neopentyl Glycol Diheptanoate
Polyester-7
Polyglyceryl-3 Distearate
Propylparaben
Simmondsia Chinensis (Jojoba) Oil
Sorbitan Isostearate
Sorbitol
Stearic Acid
Tocopherol
Triethanolamine
VP/Eicosene Copolymer
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 30  DAYLOGIC
avobenzone 2.00% homosalate 10.50% octisalate 5.00% octocrylene 2.00% oxybenzone 2.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2 mg  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	10.5 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2 mg  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Barium Sulfate (UNII: 25BB7EKE2E)
Benzyl Alcohol (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
COCONUT OIL (UNII: Q9L0O73W7L)
Dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
Polyester-7 (UNII: 0841698D2F)
Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)
Propylparaben (UNII: Z8IX2SC1OH)
JOJOBA OIL (UNII: 724GKU717M)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sorbitol (UNII: 506T60A25R)
Stearic Acid (UNII: 4ELV7Z65AP)
Tocopherol (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1113-6	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/30/2016
2	NDC: 11822-1113-9	473 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/30/2016

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-1113) , label(11822-1113)