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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

Uses • helps prevent sunburn

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

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 information • protect this product from excessive heat and
direct sun • may stain fabrics

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

image description

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-781
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.8 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-781-04118 mL in 1 TUBE; Type 0: Not a Combination Product07/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/08/2015
Labeler - Quality Choice (011920774)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(63868-781) , label(63868-781)

Revised: 6/2018
Document Id: 54575e78-54a3-4d2f-a536-4a02ad511e5b
Set id: 2ddfa23c-de49-4cb0-bb3e-5a6e66c845cc
Version: 1
Effective Time: 20180607
 
Quality Choice