Label: ULTIMATE SHEER SUNSCREEN SPF 70 QUALITY CHOICE- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.80% oxybenzone 6.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-781-04 - Packager: Quality Choice
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 7, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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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% lotionProduct 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)
