ULTIMATE SHEER SUNSCREEN SPF 70 QUALITY CHOICE- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.80% oxybenzone 6.00% lotion

Ultimate Sheer Sunscreen SPF 70 by

Drug Labeling and Warnings

Ultimate Sheer Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by Quality Choice, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                  Purpose
Avobenzone 3.0%..................................................................Sunscreen
Homosalate 15.0%.................................................................Sunscreen
Octisalate 5.0%......................................................................Sunscreen
Octocrylene 2.8%...................................................................Sunscreen
Oxybenzone 6.0%..................................................................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 may stain fabrics

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/C12-22 Alkyl Methacrylate
Copolymer, Beeswax, BHT, Caprylyl Methicone, Cetyl Dimethicone,
Dimethicone, Dimethyl Capramide, Dipotassium Glycyrrhizate, Disodium EDTA,
Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance,
Glyceryl Stearate, Methylisothiazolinone, PEG-100
Stearate, Polyaminopropyl Biguanide, Polyester-8, Silica,
Sodium Polyacrylate, Styrene/Acrylates Copolymer,
Trideceth-6, Trimethylsiloxysilicate, Water, Xanthan Gum

Questions? 248-449-9300

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTIMATE SHEER SUNSCREEN SPF 70  QUALITY CHOICE
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.80% oxybenzone 6.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-781
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2.8 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Hydrated Silica (UNII: Y6O7T4G8P9)
Methylisothiazolinone (UNII: 229D0E1QFA)
PEG-100 Stearate (UNII: YD01N1999R)
POLIHEXANIDE (UNII: 322U039GMF)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
Trideceth-6 (UNII: 3T5PCR2H0C)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-781-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	07/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/08/2015

Labeler - Quality Choice (011920774)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(63868-781) , label(63868-781)