ULTIMATE SHEER SUNSCREEN SPF 85 RITE AID- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 4.50% oxybenzone 6.00% lotion

Ultimate Sheer Sunscreen SPF 85 by

Drug Labeling and Warnings

Ultimate Sheer Sunscreen SPF 85 by is a Otc medication manufactured, distributed, or labeled by Ride Aid, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                  Purpose
Avobenzone 3.00%...............................................................Sunscreen
Homosalate 15.00%..............................................................Sunscreen
Octisalate 5.00%...................................................................Sunscreen
Octocrylene 4.50%................................................................Sunscreen
Oxybenzone 6.00%...............................................................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 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

INACTIVE INGREDIENT

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer,
Acrylates/ Dimethicone Copolymer, Beeswax, BHT,
Butyloctyl Salicylate, Cyclopentasiloxane, Dimethyl
Capramide, Dipotassium Glycyrrhizate, Disodium
EDTA, Ethylhexylglycerin, Fragrance, Glyceryl
Stearate, Methylisothiazolinone, PEG-100 Stearate,
Polyester-8, Silica, Styrene/ Acrylates Copolymer,
Triethanolamine, Water.
May Also Contain Benzisothiazoline, Chlorphenesin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTIMATE SHEER SUNSCREEN SPF 85  RITE AID
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 4.50% oxybenzone 6.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3.00 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15.00 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5.00 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	4.50 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6.00 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Methylisothiazolinone (UNII: 229D0E1QFA)
PEG-100 Stearate (UNII: YD01N1999R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1111-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/20/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/20/2014

Labeler - Ride Aid (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(11822-1111) , label(11822-1111)