NDC | 55301-777-03 |
Set ID | a702ac26-3f60-405e-8fdf-bbb3271cc18f |
Category | HUMAN OTC DRUG LABEL |
Packager | Your Military Exchanges |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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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? 866-483-2846
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SUNSCREEN SPF 70 EXCHANGE SELECT
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:55301-777 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:55301-777-03 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/23/2017 Labeler - Your Military Exchanges (001695568) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(55301-777) , label(55301-777)